Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 11:49 AM
Study NCT ID:
NCT00853957
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 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'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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', 'eventGroups': [{'id': 'EG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg', 'otherNumAtRisk': 220, 'otherNumAffected': 25, 'seriousNumAtRisk': 220, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg', 'otherNumAtRisk': 223, 'otherNumAffected': 31, 'seriousNumAtRisk': 223, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.1', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '-27.8', 'spread': '13.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.7', 'spread': '9.60', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '9.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Cumulative percentage of patients achieving BP control (\\<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Cumulative percentage of responders (Responders are defined as patients with MSSBP \\<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MSSBP at Week 1 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'classes': [{'title': 'Baseline to Week 1', 'categories': [{'measurements': [{'value': '-20.5', 'spread': '12.53', 'groupId': 'OG000'}, {'value': '-18.2', 'spread': '13.01', 'groupId': 'OG001'}]}]}, {'title': 'baseline to Week 4', 'categories': [{'measurements': [{'value': '-30.9', 'spread': '13.30', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '13.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 and 4 weeks', 'description': 'Compare the change from baseline in MSSBP at week 1 and 4', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Peripheral Edema by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'FG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg'}, {'id': 'BG001', 'title': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '9.33', 'groupId': 'BG000'}, {'value': '52.4', 'spread': '10.57', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '9.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<55 years', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': '≥55 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 443}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-26', 'studyFirstSubmitDate': '2009-02-26', 'resultsFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-22', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).'}, {'measure': 'Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)', 'timeFrame': '8 weeks', 'description': 'Cumulative percentage of patients achieving BP control (\\<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.'}, {'measure': 'Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)', 'timeFrame': '8 weeks', 'description': 'Cumulative percentage of responders (Responders are defined as patients with MSSBP \\<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.'}, {'measure': 'Change From Baseline in MSSBP at Week 1 and 4', 'timeFrame': 'Baseline, 1 and 4 weeks', 'description': 'Compare the change from baseline in MSSBP at week 1 and 4'}, {'measure': 'Percentage of Patients With Peripheral Edema by Visit', 'timeFrame': '8 weeks', 'description': "Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'African Americans', 'Aliskiren', 'Amlodipine', 'Systolic blood pressure', 'Diastolic blood pressure', 'Stage II', 'Combination'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '21925996', 'type': 'DERIVED', 'citation': 'Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women of African American 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* Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)\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\n* Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n* Evidence of a secondary form of hypertension, including but not limited to any of the following:\n\n * coarctation of the aorta\n * hyperaldosteronism\n * unilateral or bilateral renal artery stenosis\n * Cushing's disease\n * polycystic kidney disease\n * pheochromocytoma\n* Known Keith-Wagener grade III or IV hypertensive retinopathy.\n* History of angioedema due to usage of an ARB or ACE inhibitor.\n* History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months\n\nOther protocol defined inclusion/exclusion criteria applied"}, 'identificationModule': {'nctId': 'NCT00853957', 'acronym': 'AACESS', 'briefTitle': 'Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension', 'orgStudyIdInfo': {'id': 'CSPA100AUS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren/Amlodipine', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg', 'interventionNames': ['Drug: Aliskiren/Amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine', 'description': 'Amlodipine 5mg titrated to 10 mg', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'Aliskiren/Amlodipine', 'type': 'DRUG', 'description': 'Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg', 'armGroupLabels': ['Aliskiren/Amlodipine']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine 5 mg titrated to 10mg', 'armGroupLabels': ['Amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Oxon Hill', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 38.80345, 'lon': -76.9897}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Springfield Gardens', 'state': 'New York', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.66312, 'lon': -73.76221}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Milwaukeee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigative Site'}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}