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Ignite Creation Date: 2025-12-24 @ 7:00 PM

Ignite Modification Date: 2026-01-01 @ 12:20 PM

Study NCT ID: NCT00549757

Status: TERMINATED

Last Update Posted: 2014-04-21

First Post: 2007-10-24

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Core-phase: Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.', 'otherNumAtRisk': 4272, 'otherNumAffected': 3205, 'seriousNumAtRisk': 4272, 'seriousNumAffected': 1988}, {'id': 'EG001', 'title': 'Core-phase: Placebo', 'description': 'In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.', 'otherNumAtRisk': 4285, 'otherNumAffected': 3069, 'seriousNumAtRisk': 4285, 'seriousNumAffected': 1893}, {'id': 'EG002', 'title': 'Extension-phase: Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.', 'otherNumAtRisk': 3773, 'otherNumAffected': 995, 'seriousNumAtRisk': 3773, 'seriousNumAffected': 704}, {'id': 'EG003', 'title': 'Extension-phase: Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.', 'otherNumAtRisk': 3817, 'otherNumAffected': 1023, 'seriousNumAtRisk': 3817, 'seriousNumAffected': 682}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 270}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 270}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 94}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 76}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 241}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 405}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 305}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 655}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 670}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 130}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 112}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 217}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 211}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 61}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 398}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 369}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 83}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 89}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 215}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 286}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 243}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 88}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1650}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1229}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 270}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 252}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 334}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 297}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 98}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 87}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 295}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 299}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 51}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 360}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 344}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 292}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 311}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 314}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 305}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 57}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 219}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 352}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 321}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 87}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 256}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 280}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 380}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 410}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 121}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 105}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 496}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 321}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 58}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia haemolytic autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spontaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4285, 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[{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4285, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3773, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3817, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'Occurrence was defined as the first event of the following composite primary endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'description': 'Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'description': 'ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '12.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'Occurrence was defined as the first event of the following secondary renal composite endpoint:\n\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'Occurrence was defined as the first event of the following secondary renal composite endpoint:\n\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'description': 'To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'Occurrence was defined as the first event of the following composite primary endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Resuscitated Sudden Death (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With All Cause Mortality (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4272', 'groupId': 'OG000'}, {'value': '4285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'title': 'Angioedema / angioedema-like events', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Colorectal events', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'OG000'}, {'value': '4287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'title': 'Baseline to Month 6 (n= 4021, 4040)', 'categories': [{'measurements': [{'value': '0.841', 'groupId': 'OG000', 'lowerLimit': '0.820', 'upperLimit': '0.862'}, {'value': '0.945', 'groupId': 'OG001', 'lowerLimit': '0.922', 'upperLimit': '0.968'}]}]}, {'title': 'Baseline to Last Measurement (n= 4045, 4080)', 'categories': [{'measurements': [{'value': '0.872', 'groupId': 'OG000', 'lowerLimit': '0.842', 'upperLimit': '0.903'}, {'value': '1.043', 'groupId': 'OG001', 'lowerLimit': '1.009', 'upperLimit': '1.079'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Month 6 , last measurement (maximum at 50 months)', 'description': 'Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.\n\nChange from Baseline = Post - Baseline.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4113', 'groupId': 'OG000'}, {'value': '4130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.048', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.825', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 3 and Month 6', 'description': 'The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:\n\nEstimated GFR (mL/min/1.73 m\\^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)\n\nMean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3773', 'groupId': 'OG000'}, {'value': '3817', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'classes': [{'title': 'Angioedema/ Angioedema-like event', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Colorectal events', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.\n\nWith the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.\n\nWith the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}], 'periods': [{'title': 'Active Treatment Phase: Max. 50 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"Started" indicates randomized patients.', 'groupId': 'FG000', 'numSubjects': '4296'}, {'groupId': 'FG001', 'numSubjects': '4310'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4274'}, {'groupId': 'FG001', 'numSubjects': '4287'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4272'}, {'groupId': 'FG001', 'numSubjects': '4285'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4296'}, {'groupId': 'FG001', 'numSubjects': '4310'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '590'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2857'}, {'groupId': 'FG001', 'numSubjects': '3019'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': "Patient's request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '353'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'Incorrect Entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Extension Period (in Average 9 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'As explained in "pre-assignment detail", follow up was made after drug discontinuation', 'groupId': 'FG000', 'numSubjects': '3773'}, {'comment': 'As explained in "pre-assignment detail", follow up was made after drug discontinuation', 'groupId': 'FG001', 'numSubjects': '3817'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3148'}, {'groupId': 'FG001', 'numSubjects': '3182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '625'}, {'groupId': 'FG001', 'numSubjects': '635'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': "Patient's request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '421'}, {'groupId': 'FG001', 'numSubjects': '436'}]}]}], 'preAssignmentDetails': 'Per data monitoring committee (DMC) recommendation all patients were required to permanently stop study medication by 06Jan2012. A follow-up period (actual duration, 9 months in average) post study drug discontinuation on 7590 patients was implemented upon request of Health Authority following the recommendation of DMC to cease study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4274', 'groupId': 'BG000'}, {'value': '4287', 'groupId': 'BG001'}, {'value': '8561', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.\n\nWith the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.\n\nWith the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '9.62', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '9.87', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '9.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2735', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2881', 'groupId': 'BG000'}, {'value': '2945', 'groupId': 'BG001'}, {'value': '5826', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) : All patients randomized except mis-randomized patients who did not receive study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8606}}, 'statusModule': {'whyStopped': 'Lack of benefit and safety concern', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-01', 'studyFirstSubmitDate': '2007-10-24', 'resultsFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures'}, {'measure': 'Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)', 'timeFrame': 'Baseline, Month 6 , last measurement (maximum at 50 months)', 'description': 'Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.\n\nChange from Baseline = Post - Baseline.'}, {'measure': 'Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)', 'timeFrame': 'Baseline to Month 3 and Month 6', 'description': 'The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:\n\nEstimated GFR (mL/min/1.73 m\\^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)\n\nMean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms.'}, {'measure': 'Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'Occurrence was defined as the first event of the following composite primary endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.'}, {'measure': 'Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)'}, {'measure': 'Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'description': 'Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.'}, {'measure': 'Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)'}, {'measure': 'Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)'}, {'measure': 'Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'description': 'ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death'}, {'measure': 'Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)', 'description': 'To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.'}, {'measure': 'Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 Months)'}, {'measure': 'Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)'}, {'measure': 'Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'Occurrence was defined as the first event of the following composite primary endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.'}, {'measure': 'Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)', 'timeFrame': 'from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)'}, {'measure': 'Percentage of Participants With Resuscitated Sudden Death (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)'}, {'measure': 'Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)'}, {'measure': 'Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)'}, {'measure': 'Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death'}, {'measure': 'Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.'}, {'measure': 'Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)'}, {'measure': 'Percentage of Participants With All Cause Mortality (Extension Phase)', 'timeFrame': 'from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)'}, {'measure': 'Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)', 'timeFrame': 'Time from randomization to the first event (Maximum 50 months)', 'description': 'Occurrence was defined as the first event of the following secondary renal composite endpoint:\n\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.'}, {'measure': 'Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:\n\n* Cardiovascular (CV) death\n* Resuscitated sudden death\n* Non-fatal myocardial infarction (MI)\n* Non-fatal stroke\n* Unplanned hospitalization for heart failure (HF)'}, {'measure': 'Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)', 'timeFrame': 'From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)', 'description': 'Occurrence was defined as the first event of the following secondary renal composite endpoint:\n\n* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.\n* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'renal morbidity and mortality', 'cardiovascular disease', 'micro-albuminuria', 'macro-albuminuria', 'RAAS', 'renin inhibitor', 'Reduced estimated glomerular filtration rate'], 'conditions': ['Type 2 Diabetes Mellitus', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '40526444', 'type': 'DERIVED', 'citation': 'Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.'}, {'pmid': '37872654', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.'}, {'pmid': '32964800', 'type': 'DERIVED', 'citation': 'Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.'}, {'pmid': '26774608', 'type': 'DERIVED', 'citation': 'Heerspink HJ, Persson F, Brenner BM, Chaturvedi N, Brunel P, McMurray JJ, Desai AS, Solomon SD, Pfeffer MA, Parving HH, de Zeeuw D. Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi: 10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.'}, {'pmid': '23121378', 'type': 'DERIVED', 'citation': 'Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.'}, {'pmid': '19727007', 'type': 'DERIVED', 'citation': 'Lambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31. doi: 10.1097/HJH.0b013e3283310f92.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.\n\nAMENDMENT 4 RATIONALE (MARCH 2012) :\n\nProtocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes and at least one of the following:\n\n * Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2\n * Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and \\<60 mL/min/1.73 m2)\n * A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and \\<60 mL/min/1.73 m2)\n* Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Cardiovascular event or procedure ≤ 3 months prior to Visit 1\n* Unstable serum creatinine\n* Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and \\< 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and \\< 110 mmHg unless treated with at least 3 anti-hypertensive medications\n* Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg\n* Baseline Serum Potassium \\> 5.0 mmol/L\n* Patients who are treated with two renin-angiotensin-aldosterone-system-blockers\n* Patients with NYHA class III or IV heart failure\n* Known renal artery stenosis\n* Previous randomization into the AVOID trial (CSPP100C2201)\n\nEXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:\n\n\\- Aliskiren or aliskiren containing fixed combination products must not be used\n\nOther protocol-defined inclusion/exclusion criteria applied'}, 'identificationModule': {'nctId': 'NCT00549757', 'acronym': 'ALTITUDE', 'briefTitle': 'Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality', 'orgStudyIdInfo': {'id': 'CSPP100E2337'}, 'secondaryIdInfos': [{'id': '2007-000860-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren', 'description': 'In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.\n\nWith the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment', 'interventionNames': ['Drug: Aliskiren']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.\n\nWith the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Aliskiren 150 mg film-coated tablets', 'armGroupLabels': ['Aliskiren']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match aliskiren 150 mg film-coated tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, 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