Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT00942994
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2009-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
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': 'D017311', 'term': 'Amlodipine'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': 'AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.', 'otherNumAtRisk': 202, 'otherNumAffected': 22, 'seriousNumAtRisk': 202, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.', 'otherNumAtRisk': 209, 'otherNumAffected': 18, 'seriousNumAtRisk': 209, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'OG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'classes': [{'title': 'Baseline [N=202, 209]', 'categories': [{'measurements': [{'value': '167.08', 'spread': '7.277', 'groupId': 'OG000'}, {'value': '167.41', 'spread': '7.118', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 [N=197, 209]', 'categories': [{'measurements': [{'value': '130.73', 'spread': '13.06', 'groupId': 'OG000'}, {'value': '137.87', 'spread': '16.013', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to week 8 [N=197, 209]', 'categories': [{'measurements': [{'value': '-36.43', 'spread': '13.904', 'groupId': 'OG000'}, {'value': '-29.54', 'spread': '15.674', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'OG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'classes': [{'title': 'Baseline [N=202, 209]', 'categories': [{'measurements': [{'value': '95.25', 'spread': '8.985', 'groupId': 'OG000'}, {'value': '95.25', 'spread': '8.342', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 [N=197, 209]', 'categories': [{'measurements': [{'value': '80.10', 'spread': '10.317', 'groupId': 'OG000'}, {'value': '83.17', 'spread': '10.116', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to week 8 [N=197, 209]', 'categories': [{'measurements': [{'value': '-15.10', 'spread': '9.707', 'groupId': 'OG000'}, {'value': '-12.08', 'spread': '9.062', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'OG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000'}, {'value': '40.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP \\<140 mmHg and MSDBP \\<90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'OG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000'}, {'value': '72.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}, {'value': '84.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '91.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'To compare the cumulative percentage of responders (defined as patients with MSSBP \\<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.', 'unitOfMeasure': 'Percentage of Responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'OG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'classes': [{'title': 'Baseline [N=202, 209]', 'categories': [{'measurements': [{'value': '167.08', 'spread': '7.277', 'groupId': 'OG000'}, {'value': '167.41', 'spread': '7.118', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 [N=197, 209]', 'categories': [{'measurements': [{'value': '138.35', 'spread': '12.578', 'groupId': 'OG000'}, {'value': '143.77', 'spread': '13.922', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to week 2 [N=197, 209]', 'categories': [{'measurements': [{'value': '-28.81', 'spread': '12.640', 'groupId': 'OG000'}, {'value': '-23.64', 'spread': '13.673', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 [N=197, 209]', 'categories': [{'measurements': [{'value': '132.42', 'spread': '12.027', 'groupId': 'OG000'}, {'value': '140.43', 'spread': '13.961', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to week 4 [N=197, 209]', 'categories': [{'measurements': [{'value': '-34.74', 'spread': '12.145', 'groupId': 'OG000'}, {'value': '-26.98', 'spread': '13.389', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2 and Week 4', 'description': 'Primary objective at additional timepoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'OG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'classes': [{'title': 'Baseline [N=202, 209]', 'categories': [{'measurements': [{'value': '95.25', 'spread': '8.985', 'groupId': 'OG000'}, {'value': '95.25', 'spread': '8.342', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 [N=197, 209]', 'categories': [{'measurements': [{'value': '84.26', 'spread': '9.597', 'groupId': 'OG000'}, {'value': '86.24', 'spread': '8.908', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to week 2 [N=197, 209]', 'categories': [{'measurements': [{'value': '-10.95', 'spread': '8.569', 'groupId': 'OG000'}, {'value': '-9.01', 'spread': '7.872', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 [N=197, 209]', 'categories': [{'measurements': [{'value': '81.29', 'spread': '9.177', 'groupId': 'OG000'}, {'value': '85.35', 'spread': '9.567', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to week 4 [N=197, 209]', 'categories': [{'measurements': [{'value': '-13.92', 'spread': '8.891', 'groupId': 'OG000'}, {'value': '-9.91', 'spread': '7.606', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2 and Week 4', 'description': 'Secondary objective at additional timepoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'FG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren / Amlodipine / HCTZ', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.'}, {'id': 'BG001', 'title': 'Aliskiren / Amlodipine', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '9.79', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '10.19', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '10.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline characteristics are given for Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics are given for Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-16', 'studyFirstSubmitDate': '2009-07-19', 'resultsFirstSubmitDate': '2011-03-29', 'studyFirstSubmitQcDate': '2009-07-20', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-29', 'studyFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4', 'timeFrame': 'Baseline, Week 2 and Week 4', 'description': 'Primary objective at additional timepoint.'}, {'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4', 'timeFrame': 'Baseline, Week 2 and Week 4', 'description': 'Secondary objective at additional timepoint.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8', 'timeFrame': 'Baseline and week 8', 'description': 'To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8', 'timeFrame': 'Baseline and week 8', 'description': 'To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.'}, {'measure': 'Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks', 'timeFrame': '8 weeks', 'description': 'To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP \\<140 mmHg and MSDBP \\<90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.'}, {'measure': 'Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.', 'timeFrame': '8 weeks', 'description': 'To compare the cumulative percentage of responders (defined as patients with MSSBP \\<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.'}]}, 'conditionsModule': {'keywords': ['Hypertension', 'Aliskiren', 'Amlodipine', 'HCTZ', 'Systolic blood pressure', 'Diastolic blood pressure', 'Stage II', 'Combination'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '21414565', 'type': 'RESULT', 'citation': 'Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006.'}, {'pmid': '22305998', 'type': 'DERIVED', 'citation': 'Ferdinand KC, Weitzman R, Purkayastha D, Sridharan K, Jaimes EA. Aliskiren-based dual- and triple-combination therapies in high-risk US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):219-27. doi: 10.1016/j.jash.2011.12.002. Epub 2012 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.\n* Men or women 18 years and older of minority background; self-identified.\n* Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and \\<200 mmHg at Visit 5 (randomization).\n\nExclusion Criteria:\n\n* Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any visit.\n* Patients on 4 or more antihypertensive medications.\n* Patients with uncontrolled hypertension (MSSBP \\>180 mmHg) taking more than 1 antihypertensive medication at Visit 1.'}, 'identificationModule': {'nctId': 'NCT00942994', 'acronym': 'ASCENT', 'briefTitle': 'Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension', 'orgStudyIdInfo': {'id': 'CSPA100AUS02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple Therapy (Aliskiren/Amlodipine/HCTZ)', 'description': 'At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.', 'interventionNames': ['Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual Therapy (Aliskiren/Amlodipine)', 'description': 'At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.', 'interventionNames': ['Drug: Aliskiren/Amlodipine']}], 'interventions': [{'name': 'Aliskiren/Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine capsule (5 mg)\n\nAliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)', 'armGroupLabels': ['Dual Therapy (Aliskiren/Amlodipine)']}, {'name': 'Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)', 'type': 'DRUG', 'description': 'Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)\n\nHCTZ capsule (12.5 mg, 25mg)', 'armGroupLabels': ['Triple Therapy (Aliskiren/Amlodipine/HCTZ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72201', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'K and S Research Services', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Well Pharma Medical Research', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '02126', 'city': 'Mattapan', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Hyde Park Health Associates', 'geoPoint': {'lat': 42.27232, 'lon': -71.087}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Scriber Kidney Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}