Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 2:23 PM
Study NCT ID:
NCT00529451
Status:
COMPLETED
Last Update Posted:
2011-03-25
First Post:
2007-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}, {'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'One randomized patient in the Ramipril group never received blinded study medication. The subject is therefore not included in the "at risk" population.', 'eventGroups': [{'id': 'EG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily', 'otherNumAtRisk': 331, 'otherNumAffected': 4, 'seriousNumAtRisk': 331, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily', 'otherNumAtRisk': 323, 'otherNumAffected': 3, 'seriousNumAtRisk': 323, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily', 'otherNumAtRisk': 332, 'otherNumAffected': 2, 'seriousNumAtRisk': 332, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily', 'otherNumAtRisk': 329, 'otherNumAffected': 17, 'seriousNumAtRisk': 329, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 332, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily'}, {'id': 'OG001', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily'}, {'id': 'OG002', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily'}, {'id': 'OG003', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'classes': [{'title': 'msSBP', 'categories': [{'measurements': [{'value': '-14.39', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-12.16', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-12.24', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-11.46', 'spread': '0.66', 'groupId': 'OG003'}]}]}, {'title': 'msDBP', 'categories': [{'measurements': [{'value': '-11.63', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-10.04', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-10.66', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-9.19', 'spread': '0.44', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily'}, {'id': 'OG001', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily'}, {'id': 'OG002', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily'}, {'id': 'OG003', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '52.29', 'groupId': 'OG000'}, {'value': '48.11', 'groupId': 'OG001'}, {'value': '45.68', 'groupId': 'OG002'}, {'value': '43.65', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'To evaluate the percentage of patients controlled to a target blood pressure of \\< 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily'}, {'id': 'OG001', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily'}, {'id': 'OG002', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily'}, {'id': 'OG003', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '67.89', 'groupId': 'OG000'}, {'value': '59.75', 'groupId': 'OG001'}, {'value': '59.57', 'groupId': 'OG002'}, {'value': '53.87', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP \\< 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.'}, {'type': 'PRIMARY', 'title': 'Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily'}, {'id': 'OG001', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.63', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-9.19', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.44', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '-1.25', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin of 2.25 mm Hg'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.'}, {'type': 'PRIMARY', 'title': 'Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily'}, {'id': 'OG001', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.04', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-9.19', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '0.34', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin of 2.25 mm Hg'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.'}, {'type': 'PRIMARY', 'title': 'Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily'}, {'id': 'OG001', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.66', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-9.19', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.48', 'ciLowerLimit': '-2.67', 'ciUpperLimit': '-0.28', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin of 2.25 mm Hg'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily'}, {'id': 'FG001', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily'}, {'id': 'FG002', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily'}, {'id': 'FG003', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '331'}, {'groupId': 'FG001', 'numSubjects': '323'}, {'groupId': 'FG002', 'numSubjects': '332'}, {'groupId': 'FG003', 'numSubjects': '330'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '275'}, {'groupId': 'FG002', 'numSubjects': '292'}, {'groupId': 'FG003', 'numSubjects': '299'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Unsatisfactory therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'BG000'}, {'value': '323', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}, {'value': '330', 'groupId': 'BG003'}, {'value': '1316', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily'}, {'id': 'BG001', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily'}, {'id': 'BG002', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily'}, {'id': 'BG003', 'title': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '9.45', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '10.53', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '10.22', 'groupId': 'BG002'}, {'value': '52.9', 'spread': '9.60', 'groupId': 'BG003'}, {'value': '53.2', 'spread': '9.95', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}, {'value': '1142', 'groupId': 'BG004'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}, {'value': '585', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '731', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1613}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2007-09-12', 'resultsFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-28', 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint'}, {'measure': 'Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint'}, {'measure': 'Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint', 'timeFrame': 'Baseline and Week 8', 'description': 'To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.'}, {'measure': 'Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg', 'timeFrame': 'Week 8', 'description': 'To evaluate the percentage of patients controlled to a target blood pressure of \\< 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.'}, {'measure': 'Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP', 'timeFrame': 'Week 8', 'description': 'To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP \\< 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension, Aliskiren, Ramipril'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '33089502', 'type': 'DERIVED', 'citation': 'Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have msDBP ≥ 90 mmHg and \\< 110 mmHg at the visit immediately prior to Visit 3\n* Patients must have msDBP \\>OR= 95 mmHg and \\< 110 mmHg at Visit 3\n* Patients must have an absolute difference of \\< or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3\n\nExclusion Criteria:\n\n* Severe hypertension (grade 3 WHO classification; msDBP \\>or= 110 mmHg and/or msSBP \\>or = 180 mmHg).\n* History or evidence of a secondary form of hypertension.\n* History of transient ischemic cerebral attack within 12 months of visit 1.\n* Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)\n* Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) \\> 8% at Visit 1.\n* Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00529451', 'briefTitle': 'Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Eight Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'CSPP100A2339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg once daily', 'interventionNames': ['Drug: Aliskiren']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg once daily', 'interventionNames': ['Drug: Aliskiren']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg once daily', 'interventionNames': ['Drug: Aliskiren']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ramipril 5 mg', 'description': 'Ramipril 5 mg once daily', 'interventionNames': ['Drug: Ramipril']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Aliskiren', 'armGroupLabels': ['Aliskiren 150 mg', 'Aliskiren 300 mg', 'Aliskiren 75 mg']}, {'name': 'Ramipril', 'type': 'DRUG', 'description': 'comparator', 'armGroupLabels': ['Ramipril 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'China', 'country': 'China', 'facility': 'Novartis Investigative Sites'}, {'city': 'India', 'country': 'India', 'facility': 'Novartis Investigative Sites', 'geoPoint': {'lat': 23.01533, 'lon': 75.36261}}, {'city': 'Thailand', 'country': 'Thailand', 'facility': 'Novartis Investigative Sites'}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}