Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT00923156
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2009-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054160', 'term': 'Systolic Murmurs'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006337', 'term': 'Heart Murmurs'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}, {'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Reported adverse events summarized events of the run-in period and double blind period. All serious adverse (SAEs) events were not suspected to be related to study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.', 'otherNumAtRisk': 42, 'otherNumAffected': 6, 'seriousNumAtRisk': 42, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.', 'otherNumAtRisk': 40, 'otherNumAffected': 3, 'seriousNumAtRisk': 40, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Ramipril + Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.', 'otherNumAtRisk': 41, 'otherNumAffected': 7, 'seriousNumAtRisk': 41, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Venous Angiotensin II Levels After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'OG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'OG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}], 'classes': [{'title': '0 Hour pre-dose (n=40, 38, 37)', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '1.59'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '1.81'}, {'value': '0.66', 'groupId': 'OG002', 'lowerLimit': '0.37', 'upperLimit': '1.18'}]}]}, {'title': '3 hour post-dose (n=40, 38, 38)', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.62'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.78'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.22', 'upperLimit': '0.66'}]}]}, {'title': '24 hour post-dose (n=40, 38, 38)', 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '1.41'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '1.60'}, {'value': '0.64', 'groupId': 'OG002', 'lowerLimit': '0.34', 'upperLimit': '1.24'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline. 12 Weeks (Day 84, period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category "n" indicates patients with observations at that time point.'}, {'type': 'SECONDARY', 'title': 'Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'OG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'OG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '1.67', 'upperLimit': '3.66'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '1.30'}, {'value': '4.67', 'groupId': 'OG002', 'lowerLimit': '2.80', 'upperLimit': '7.78'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 12 weeks (84 days, period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.'}, {'type': 'SECONDARY', 'title': 'Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'OG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'OG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}], 'classes': [{'title': '0 hour pre-dose (n=40,38,37)', 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.24'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '1.52'}, {'value': '0.25', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.41'}]}]}, {'title': '3 hour post-dose (n=40,38,38)', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.14'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '2.61'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.24'}]}]}, {'title': '24 hour post-dose (n=40,38,38)', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.22'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.58', 'upperLimit': '1.40'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.11', 'upperLimit': '0.25'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline,12 weeks (84 days, Period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category "n" indicates patients with observations at that time point.'}, {'type': 'SECONDARY', 'title': 'Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'OG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'OG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.16'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '1.03'}, {'value': '0.78', 'groupId': 'OG002', 'lowerLimit': '0.64', 'upperLimit': '0.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 12 weeks (Day 84 period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.'}, {'type': 'SECONDARY', 'title': 'Biomarker Urinary Aldosterone After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'OG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'OG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.08'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.18'}, {'value': '0.87', 'groupId': 'OG002', 'lowerLimit': '0.63', 'upperLimit': '1.21'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline,12 weeks (Day 84 period 2)', 'description': '24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '1.7896', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '7.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '257.2', 'spread': '270.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '1707', 'spread': '1321.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '3041', 'spread': '1669.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '3502', 'spread': '1907.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.02', 'spread': '10.624', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'FG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'FG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"Started" indicates randomized, safety and pharmacodynamic population', 'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Abnormal laboratory values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Patient enrolled to 4 week open label run-in phase (period 1) to up-titrate ramipril dose. 123 patients were randomized on Day 1 of Period 2 in a double-blind fashion to one of the three (1:1:1) treatment arms. The double-blind period was for 12 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.'}, {'id': 'BG001', 'title': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.'}, {'id': 'BG002', 'title': 'Aliskiren Plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '9.00', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '9.91', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '10.47', 'groupId': 'BG002'}, {'value': '62.6', 'spread': '9.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-19', 'studyFirstSubmitDate': '2009-06-17', 'resultsFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-01', 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Angiotensin II Levels After 12 Weeks of Treatment', 'timeFrame': 'Baseline. 12 Weeks (Day 84, period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose.'}], 'secondaryOutcomes': [{'measure': 'Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment', 'timeFrame': 'Baseline, 12 weeks (84 days, period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose.'}, {'measure': 'Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment', 'timeFrame': 'Baseline,12 weeks (84 days, Period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose.'}, {'measure': 'Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment', 'timeFrame': 'Baseline, 12 weeks (Day 84 period 2)', 'description': 'Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose.'}, {'measure': 'Biomarker Urinary Aldosterone After 12 Weeks of Treatment', 'timeFrame': 'Baseline,12 weeks (Day 84 period 2)', 'description': '24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose.'}, {'measure': 'Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.'}, {'measure': 'Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.'}, {'measure': 'Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.'}, {'measure': 'Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.'}, {'measure': 'Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.'}, {'measure': 'Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)', 'timeFrame': '12 weeks', 'description': 'Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.'}]}, 'conditionsModule': {'keywords': ['Heart failure', 'Systolic', 'Aliskiren', 'Ramipril', 'Angiotensin II', 'Ang II', 'Plasma Renin Activity', 'PRA', 'Plasma Renin Concentration', 'PR,', 'brain natriuretic peptide', 'BNP', 'urinary aldosterone', 'Escape', 'Pharmacokinetic', 'PK'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33089502', 'type': 'DERIVED', 'citation': 'Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.'}]}, 'descriptionModule': {'briefSummary': 'In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the blood in patients with systolic heart failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Decompensated systolic heart failure, left ventricular ejection fraction ≤40%\n* Brain natriuretic peptide (BNP) level ≥ 100 pg/mL\n\nExclusion criteria:\n\n* Use of Angiotensin Converting Enzyme(ACE) or Angiotensin Receptor Blocker (ARB) inhibitor treatment following the run-in period or requirement of both treatments\n* Acute heart failure secondary to acute myocardial infarction, acute coronary syndrome or new tachyarrhythmia\n* Occurrence of unstable angina or myocardial infarction within 12 weeks prior to screening\n* History of cardiomyopathy such as postpartum, restrictive, infective, hypertrophic obstructive\n* History of right heart failure due to pulmonary disease\n* History of untreated second or third degree atrioventricular heart block\n\nOther protocol-defined inclusion/exclusion criteria applied'}, 'identificationModule': {'nctId': 'NCT00923156', 'acronym': 'ESCAPE-SHF', 'briefTitle': 'Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'ESCAPE-SHF: A Double-blind, Double-dummy, Randomized, Multicenter, Parallel Group Study to Evaluate the Effects of Aliskiren, Ramipril and Combination Treatment on Plasma Concentration of Angiotensin II in Patients With Decompensated Systolic Heart Failure', 'orgStudyIdInfo': {'id': 'CSPP100A2252'}, 'secondaryIdInfos': [{'id': 'EudraCT 2008-001035-35'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.', 'interventionNames': ['Drug: aliskiren', 'Drug: ramipril', 'Drug: Placebo to ramipril']}, {'type': 'EXPERIMENTAL', 'label': 'Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.', 'interventionNames': ['Drug: ramipril', 'Drug: Placebo to aliskiren']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren plus Ramipril', 'description': 'In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.\n\nIn double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site', 'interventionNames': ['Drug: aliskiren', 'Drug: ramipril']}], 'interventions': [{'name': 'aliskiren', 'type': 'DRUG', 'description': 'Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site', 'armGroupLabels': ['Aliskiren', 'Aliskiren plus Ramipril']}, {'name': 'ramipril', 'type': 'DRUG', 'description': '2.5 mg , 5.0 mg or 10 mg once daily', 'armGroupLabels': ['Aliskiren', 'Aliskiren plus Ramipril', 'Ramipril']}, {'name': 'Placebo to aliskiren', 'type': 'DRUG', 'description': 'matching placebo to aliskiren in double blind phase', 'armGroupLabels': ['Ramipril']}, {'name': 'Placebo to ramipril', 'type': 'DRUG', 'description': 'Matching placebo to ramipril capsule in double blind phase', 'armGroupLabels': ['Aliskiren']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '12207', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '37057', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-090', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '61-848', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-981', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '117292', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119620', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121309', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}