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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 9:44 PM

Ignite Modification Date: 2026-01-01 @ 2:10 PM

Study NCT ID: NCT00810732

Status: COMPLETED

Last Update Posted: 2023-07-06

First Post: 2008-12-17

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects

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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106276', 'term': 'sitaxsentan'}, {'id': 'D009543', 'term': 'Nifedipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitaxsentan', 'description': 'Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period.', 'otherNumAtRisk': 27, 'otherNumAffected': 13, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants administered placebo matched to 100 mg tablets orally, once daily for 6 weeks in either first, second or third intervention period.', 'otherNumAtRisk': 27, 'otherNumAffected': 21, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nifedipine', 'description': 'Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention period.', 'otherNumAtRisk': 27, 'otherNumAffected': 18, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Change of bowel habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Balanitis candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Infusion site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo matched to 100 mg tablets orally, once daily for 6 weeks in either first, second or third intervention period.'}, {'id': 'OG002', 'title': 'Nifedipine', 'description': 'Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention period.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.07', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '1.95', 'spread': '1.58', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 6', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7945', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.', 'unitOfMeasure': 'Grams per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo matched to 100 mg tablets orally, once daily for 6 weeks in either first, second or third intervention period.'}, {'id': 'OG002', 'title': 'Nifedipine', 'description': 'Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention period.'}], 'classes': [{'title': 'Mean Systemic Arterial BP: Baseline', 'categories': [{'measurements': [{'value': '92.94', 'spread': '7.39', 'groupId': 'OG000'}, {'value': '92.98', 'spread': '9.33', 'groupId': 'OG001'}, {'value': '93.78', 'spread': '8.35', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial BP: Change at Week 3', 'categories': [{'measurements': [{'value': '-4.59', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '4.70', 'groupId': 'OG001'}, {'value': '-2.95', 'spread': '5.90', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial BP: Change at Week 6', 'categories': [{'measurements': [{'value': '-3.74', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '5.38', 'groupId': 'OG001'}, {'value': '-3.54', 'spread': '5.49', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial SBP :Baseline', 'categories': [{'measurements': [{'value': '124.03', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '125.17', 'spread': '13.95', 'groupId': 'OG001'}, {'value': '125.12', 'spread': '12.33', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial SBP: Change at Week 3', 'categories': [{'measurements': [{'value': '-4.88', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '-2.81', 'spread': '7.21', 'groupId': 'OG001'}, {'value': '-4.20', 'spread': '7.67', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial SBP: Change at Week 6', 'categories': [{'measurements': [{'value': '-3.99', 'spread': '7.82', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '7.22', 'groupId': 'OG001'}, {'value': '-4.47', 'spread': '7.97', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial DBP: Baseline', 'categories': [{'measurements': [{'value': '77.56', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '77.58', 'spread': '8.05', 'groupId': 'OG001'}, {'value': '78.27', 'spread': '7.74', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial DBP: Change at Week 3', 'categories': [{'measurements': [{'value': '-4.85', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '3.98', 'groupId': 'OG001'}, {'value': '-2.09', 'spread': '5.59', 'groupId': 'OG002'}]}]}, {'title': 'Mean Systemic Arterial DBP: Change at Week 6', 'categories': [{'measurements': [{'value': '-3.60', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '5.03', 'groupId': 'OG001'}, {'value': '-2.86', 'spread': '4.92', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.50', 'ciLowerLimit': '-6.08', 'ciUpperLimit': '-0.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.30', 'groupDescription': 'Mean Systemic Arterial BP: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1424', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.92', 'ciLowerLimit': '-4.50', 'ciUpperLimit': '0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.30', 'groupDescription': 'Mean Systemic Arterial BP: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2277', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-4.15', 'ciUpperLimit': '1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'groupDescription': 'Mean Systemic Arterial BP: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1599', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-6.16', 'ciUpperLimit': '1.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.81', 'groupDescription': 'Systolic Blood Pressure: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5545', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-4.66', 'ciUpperLimit': '2.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.80', 'groupDescription': 'Systolic Blood Pressure: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4095', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.49', 'ciLowerLimit': '-5.08', 'ciUpperLimit': '2.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.80', 'groupDescription': 'Systolic Blood Pressure: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.08', 'ciLowerLimit': '-6.49', 'ciUpperLimit': '-1.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.21', 'groupDescription': 'Diastolic Blood Pressure: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0159', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.98', 'ciLowerLimit': '-5.38', 'ciUpperLimit': '-0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.21', 'groupDescription': 'Diastolic Blood Pressure: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3627', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-3.51', 'ciUpperLimit': '1.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.21', 'groupDescription': 'Diastolic Blood Pressure: Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.36', 'ciLowerLimit': '-5.69', 'ciUpperLimit': '-1.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.16', 'groupDescription': 'Mean Systemic Arterial BP: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6503', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-2.86', 'ciUpperLimit': '1.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.16', 'groupDescription': 'Mean Systemic Arterial BP: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0183', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.83', 'ciLowerLimit': '-5.16', 'ciUpperLimit': '-0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.16', 'groupDescription': 'Mean Systemic Arterial BP: Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0726', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.81', 'ciLowerLimit': '-5.89', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.53', 'groupDescription': 'Systolic Blood Pressure (SBP): Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9661', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-3.01', 'ciUpperLimit': '3.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.53', 'groupDescription': 'Systolic Blood Pressure (SBP): Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0656', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.88', 'ciLowerLimit': '-5.94', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.53', 'groupDescription': 'Systolic Blood Pressure (SBP): Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.16', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '-0.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'groupDescription': 'Diastolic Blood Pressure (DBP): Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3760', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '1.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'groupDescription': 'Diastolic Blood Pressure (DBP): Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0572', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.16', 'ciLowerLimit': '-4.40', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'groupDescription': 'Diastolic Blood Pressure (DBP): Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3 and 6', 'description': "The 24-hour ambulatory BP monitoring was performed by using a BP cuff which was attached to the participant's arm, using the same arm throughout the study, with a small monitor that comfortably sits in the pocket of participant. Mean values over 24-hour measurements at each measurement period were calculated. The change in total 24-hour ambulatory monitoring of systemic arterial BP, SBP and DBP at Week 3 and 6 relative to baseline were reported. Baseline was as an average of the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.", 'unitOfMeasure': 'Millimeter of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered placebo matched to 100 mg tablets orally, once daily for 6 weeks in either first, second or third intervention period.'}, {'id': 'OG002', 'title': 'Nifedipine', 'description': 'Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention period.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.97', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '7.74', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '7.94', 'spread': '1.74', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 3', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '0.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9457', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9358', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': 'Week 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8956', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0030', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3 and 6', 'description': 'Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Baseline was defined as the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.', 'unitOfMeasure': 'Meter per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Then Sitaxsentan Then Nifedipine', 'description': 'Participants received placebo matched to Sitaxsentan 100 milligram (mg) tablet orally, once daily for 6 weeks in first intervention period, then Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Nifedipine extended release (ER) 30 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}, {'id': 'FG001', 'title': 'Sitaxsentan Then Nifedipine Then Placebo', 'description': 'Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in first intervention period, then nifedipine ER 30 mg tablet orally, once daily for 6 weeks in second intervention period, followed by placebo matched Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}, {'id': 'FG002', 'title': 'Nifedipine Then Sitaxsentan Then Placebo', 'description': 'Participants received Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in first intervention period, then Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}, {'id': 'FG003', 'title': 'Nifedipine Then Placebo Then Sitaxsentan', 'description': 'Participants received Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in first intervention period, then placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}, {'id': 'FG004', 'title': 'Placebo Then Nifedipine Then Sitaxsentan', 'description': 'Participants received placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in first intervention period, then Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}, {'id': 'FG005', 'title': 'Sitaxsentan Then Placebo Then Nifedipine', 'description': 'Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in first intervention period, then placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}], 'periods': [{'title': 'First Intervention Period (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'First Washout Period (at Least 2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention Period (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Washout Period (at Least 2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention Period (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'All participants who were randomized to receive Sitaxsentan 100 mg tablet, Nifedipine ER 30 mg tablet and placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in any intervention period. Each intervention period was separated by a washout period of at least 2 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2012-01-27', 'completionDateStruct': {'date': '2009-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2008-12-17', 'dispFirstSubmitQcDate': '2012-08-08', 'resultsFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2008-12-17', 'dispFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-04', 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6', 'timeFrame': 'Baseline, Week 3 and 6', 'description': "The 24-hour ambulatory BP monitoring was performed by using a BP cuff which was attached to the participant's arm, using the same arm throughout the study, with a small monitor that comfortably sits in the pocket of participant. Mean values over 24-hour measurements at each measurement period were calculated. The change in total 24-hour ambulatory monitoring of systemic arterial BP, SBP and DBP at Week 3 and 6 relative to baseline were reported. Baseline was as an average of the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period."}, {'measure': 'Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6', 'timeFrame': 'Baseline, Week 3 and 6', 'description': 'Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Baseline was defined as the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Sitaxsentan'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '31177906', 'type': 'DERIVED', 'citation': 'Farrah TE, Anand A, Gallacher PJ, Kimmitt R, Carter E, Dear JW, Mills NL, Webb DJ, Dhaun N. Endothelin Receptor Antagonism Improves Lipid Profiles and Lowers PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in Patients With Chronic Kidney Disease. Hypertension. 2019 Aug;74(2):323-330. doi: 10.1161/HYPERTENSIONAHA.119.12919. Epub 2019 Jun 10.'}, {'pmid': '25801761', 'type': 'DERIVED', 'citation': 'Dhaun N, Yuzugulen J, Kimmitt RA, Wood EG, Chariyavilaskul P, MacIntyre IM, Goddard J, Webb DJ, Corder R. Plasma pro-endothelin-1 peptide concentrations rise in chronic kidney disease and following selective endothelin A receptor antagonism. J Am Heart Assoc. 2015 Mar 23;4(3):e001624. doi: 10.1161/JAHA.114.001624.'}, {'pmid': '24890823', 'type': 'DERIVED', 'citation': 'Dhaun N, Moorhouse R, MacIntyre IM, Melville V, Oosthuyzen W, Kimmitt RA, Brown KE, Kennedy ED, Goddard J, Webb DJ. Diurnal variation in blood pressure and arterial stiffness in chronic kidney disease: the role of endothelin-1. Hypertension. 2014 Aug;64(2):296-304. doi: 10.1161/HYPERTENSIONAHA.114.03533.'}, {'pmid': '23243212', 'type': 'DERIVED', 'citation': 'Dhaun N, Melville V, Blackwell S, Talwar DK, Johnston NR, Goddard J, Webb DJ. Endothelin-A receptor antagonism modifies cardiovascular risk factors in CKD. J Am Soc Nephrol. 2013 Jan;24(1):31-6. doi: 10.1681/ASN.2012040355. Epub 2012 Dec 14.'}, {'pmid': '21357275', 'type': 'DERIVED', 'citation': 'Dhaun N, MacIntyre IM, Kerr D, Melville V, Johnston NR, Haughie S, Goddard J, Webb DJ. Selective endothelin-A receptor antagonism reduces proteinuria, blood pressure, and arterial stiffness in chronic proteinuric kidney disease. Hypertension. 2011 Apr;57(4):772-9. doi: 10.1161/HYPERTENSIONAHA.110.167486. Epub 2011 Feb 28.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321005&StudyName=Effects%20Of%20Sitaxsentan%20On%20Proteinuria%2C%2024-Hour%20Blood%20Pressure%2C%20And%20Arterial%20Stiffness%20In%20Chronic%20Kidney%20Disease%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.\n\nExclusion Criteria:\n\n* Required peritoneal dialysis or haemodialysis.\n* Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.'}, 'identificationModule': {'nctId': 'NCT00810732', 'acronym': 'FCRD01', 'briefTitle': 'Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'THE EFFECTS OF SITAXSENTAN ONCE DAILY DOSING ON PROTEINURIA, 24-HOUR BLOOD PRESSURE, AND ARTERIAL STIFFNESS IN SUBJECTS WITH CHRONIC KIDNEY DISEASE', 'orgStudyIdInfo': {'id': 'B1321005'}, 'secondaryIdInfos': [{'id': 'B1321005'}, {'id': '2006-002004-33', 'type': 'EUDRACT_NUMBER'}, {'id': 'FCRD01', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitaxsentan', 'description': 'Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)', 'interventionNames': ['Drug: Open']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nifedipine', 'description': 'Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)', 'interventionNames': ['Drug: Nifedipine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for sitaxsentan, orally administered once daily (double blind arm)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Open', 'type': 'DRUG', 'otherNames': ['Sitaxsentan'], 'description': 'Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)', 'armGroupLabels': ['Sitaxsentan']}, {'name': 'Nifedipine', 'type': 'DRUG', 'description': 'Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm)', 'armGroupLabels': ['Nifedipine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for sitaxsentan, orally administered once daily (double blind arm)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Clinical Research Centre and Pharmacology Unit', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'the University of Edinburgh, Western General Hospital, Department of Medical Sciences', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}