Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT00498433
Status:
TERMINATED
Last Update Posted:
2014-09-10
First Post:
2007-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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 or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Population consisted of all patients that received at least one dose of study drug with at least one post-baseline safety assessment.\n\nIn Part 1 of the study, no events were reported in period 1 when patients received placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Aliskiren', 'description': 'All eligible patients received 4 week treatment of 300 mg aliskiren o.d..', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: Amlodipine', 'description': 'All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 2: Placebo run-in Period', 'description': 'After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.', 'otherNumAtRisk': 36, 'otherNumAffected': 1, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 2: Aliskiren', 'description': 'Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2: Amlodipine', 'description': 'Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCLE STRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'POST PROCEDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ERECTILE DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'MUSCLE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'title': 'Adipose tissue', 'categories': [{'measurements': [{'value': '2.38', 'spread': '2.11', 'groupId': 'OG000'}]}]}, {'title': 'Skeletal muscle', 'categories': [{'measurements': [{'value': '7.05', 'spread': '4.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 42', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'timeFrame': 'Day 98', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes.'}, {'type': 'SECONDARY', 'title': 'Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Day 14 and Day 98', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in Official Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'PRIMARY', 'title': 'Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'timeFrame': 'Day 42', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to technical limitations, zero flow concentrations could not be derived for Ang II.'}, {'type': 'PRIMARY', 'title': 'Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'timeFrame': 'Day 98', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to technical limitations, zero flow concentrations could not be derived for Ang II.'}, {'type': 'PRIMARY', 'title': 'Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'title': 'Adipose tissue (n=6)', 'categories': [{'measurements': [{'value': '29.05', 'spread': '16.71', 'groupId': 'OG000'}]}]}, {'title': 'Skeletal muscle (n=9)', 'categories': [{'measurements': [{'value': '107.32', 'spread': '68.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 42', 'description': 'Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'timeFrame': 'Day 42', 'description': 'Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.', 'reportingStatus': 'POSTED', 'populationDescription': 'More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received.'}, {'type': 'PRIMARY', 'title': 'Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'timeFrame': 'Day 42', 'reportingStatus': 'POSTED', 'populationDescription': 'Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points.'}, {'type': 'PRIMARY', 'title': 'Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.38', 'spread': '4.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 42', 'description': 'Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.78', 'spread': '3.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 98', 'description': 'Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.534', 'groupId': 'OG000', 'lowerLimit': '0.223', 'upperLimit': '1.28'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 42', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.', 'unitOfMeasure': 'fmol/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '5.51'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 98', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.', 'unitOfMeasure': 'fmol/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'title': 'Plasma Renin Concentration', 'categories': [{'measurements': [{'value': '22.29', 'groupId': 'OG000', 'lowerLimit': '8.98', 'upperLimit': '55.32'}]}]}, {'title': 'Total Renin Concentration', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '154.2'}]}]}, {'title': 'Prorenin Concentration', 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '96.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 42', 'description': 'Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'title': 'Plasma Renin Concentration', 'categories': [{'measurements': [{'value': '7.36', 'groupId': 'OG000', 'lowerLimit': '4.24', 'upperLimit': '12.80'}]}]}, {'title': 'Total Renin Concentration', 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '88.2'}]}]}, {'title': 'Prorenin Concentration', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '44.1', 'upperLimit': '76.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 98', 'description': 'Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Renin Activity From Plasma During Aliskiren Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.145', 'groupId': 'OG000', 'lowerLimit': '0.055', 'upperLimit': '0.386'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 42', 'description': 'Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.', 'unitOfMeasure': 'ng/nl/h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 1: Renin Activity From Plasma During Amlodipine Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.670', 'groupId': 'OG000', 'lowerLimit': '0.269', 'upperLimit': '1.672'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 98', 'description': 'Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.', 'unitOfMeasure': 'ng/nl/h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'PRIMARY', 'title': 'Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'description': 'Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'PRIMARY', 'title': 'Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Day 98', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'PRIMARY', 'title': 'Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Day 98', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG001', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo run-in', 'description': 'Part 2, Period 1, Placebo run-in phase: After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.'}, {'id': 'OG001', 'title': 'Aliskiren', 'description': 'Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'OG002', 'title': 'Amlodipine', 'description': 'Part 2, Double Blind: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'classes': [{'title': 'Adverse event', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '98 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted of all patients who received at least one dose of study drug with at least one post-baseline safety assessment. Patients were analyzed according to treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase.'}, {'id': 'FG001', 'title': 'Aliskiren', 'description': 'Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'FG002', 'title': 'Amlodipine', 'description': 'Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.\n\nPart 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}], 'periods': [{'title': 'Part 1, Period 1:Placebo Run-in(2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 1, Period 2: Aliskiren (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 1, Period 3: Amlodipine (4-8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Placebo Run-in (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'comment': 'For part 2, this arm belongs to randomized, double blind period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'For part 2, this arm belongs to randomized, double blind period.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Double Blind (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Total 46 patients entered into the study; 10 patients in part 1 received study drug. 36 patients enrolled into part 2 and and 16 patients received study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Placebo/Aliskiren/Amlodipine', 'description': 'Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.\n\nPart 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..\n\nPart 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.'}, {'id': 'BG001', 'title': 'Part 2, Double Blind Period: Aliskiren', 'description': 'Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks'}, {'id': 'BG002', 'title': 'Part 2, Double Blind: Amlodipine', 'description': 'Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1, Open Label', 'categories': [{'measurements': [{'value': '46', 'spread': '7.5', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm is used for part 2, double blind period', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm is used for part 2, double blind period', 'groupId': 'BG002'}, {'value': '46', 'spread': '7.5', 'groupId': 'BG003'}]}]}, {'title': 'Part 2, Double blind', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This arm is used for part 1, open label .', 'groupId': 'BG000'}, {'value': '46.0', 'spread': '10.92', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '10.53', 'groupId': 'BG002'}, {'value': '47.7', 'spread': '10.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Part 1 : Baseline measures are on all patients.\n\nPart 2: Randomized population of double-blind period used for Baseline/Demographic measurements.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Early termination resulted from interim analysis of the ALTITUDE trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2007-07-08', 'resultsFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2007-07-08', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-23', 'studyFirstPostDateStruct': {'date': '2007-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).'}, {'measure': 'Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period', 'timeFrame': 'Day 98', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).'}, {'measure': 'Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.'}, {'measure': 'Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period', 'timeFrame': 'Day 98', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.'}, {'measure': 'Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).'}, {'measure': 'Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.'}, {'measure': 'Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period', 'timeFrame': 'Day 42'}, {'measure': 'Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).'}, {'measure': 'Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period', 'timeFrame': 'Day 98', 'description': 'Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).'}, {'measure': 'Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.'}, {'measure': 'Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period', 'timeFrame': 'Day 98', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.'}, {'measure': 'Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).'}, {'measure': 'Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period', 'timeFrame': 'Day 98', 'description': 'Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).'}, {'measure': 'Part 1: Renin Activity From Plasma During Aliskiren Treatment Period', 'timeFrame': 'Day 42', 'description': 'Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.'}, {'measure': 'Part 1: Renin Activity From Plasma During Amlodipine Treatment Period', 'timeFrame': 'Day 98', 'description': 'Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.'}, {'measure': 'Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period', 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'description': 'Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.'}, {'measure': 'Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period', 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)', 'description': 'Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).'}, {'measure': 'Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period', 'timeFrame': 'Day 98'}, {'measure': 'Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period', 'timeFrame': 'Day 98'}], 'secondaryOutcomes': [{'measure': 'Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)', 'timeFrame': 'Day 14 and Day 98'}, {'measure': 'Part 2: Change From Baseline in Official Blood Pressure', 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)'}, {'measure': 'Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid', 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)'}, {'measure': 'Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)', 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)'}, {'measure': 'Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)', 'timeFrame': 'Placebo Baseline (Day 14), Active Treatment (Day 98)'}, {'measure': 'Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death', 'timeFrame': '98 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aliskiren', 'Renin-Angiotensin System (RAS)', 'Hypertension', 'Abdominal obesity'], 'conditions': ['Hypertension', 'Abdominal Obesity']}, 'descriptionModule': {'briefSummary': 'Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.\n\nPart 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPART 1:\n\n* Male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)\n* For patients with a history of treated hypertension, mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80 mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg\n* Pulse rate 40 - 90 bpm\n\nPART 2:\n\n* Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)\n* Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:\n\n 1. Patients with history of treated hypertension: msSBP/msDBP ≥ 135/85 mmHg and \\< 160/100 mmHg at baseline\n 2. Patients with newly diagnosed, untreated hypertension: msSBP/msDBP ≥ 135/85 mmHg and \\< 160/100 mmHg at screening and baseline.\n\nExclusion criteria:\n\nPART 1\n\n* Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) WHO classification\n* Current treatment with three or more antihypertensive drugs.\n\nPART 2\n\n* Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg).\n* Current treatment with three or more antihypertensive drugs.\n\nOther protocol-defined inclusion/exclusion criteria applied'}, 'identificationModule': {'nctId': 'NCT00498433', 'briefTitle': 'Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Part 1: An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity. Part 2: A Randomized, Double Blind, 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity', 'orgStudyIdInfo': {'id': 'CSPP100A2238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren', 'description': 'Part 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase (period 1) consisting of treatment with one tablet of placebo to aliskiren once daily (o.d.). This was followed by a 4 week treatment phase (period 2) consisting of treatment with 300 mg aliskiren o.d..\n\nPart 2: Eligible randomized patients in this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks.', 'interventionNames': ['Drug: Aliskiren', 'Drug: Placebo of Aliskiren', 'Drug: Placebo of amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine', 'description': 'Part 1: After aliskiren treatment (period 2), each patient was entered into a second washout period (4 weeks) during which blood pressure was required to be ≤ 140/90 mmHg. If blood pressure exceeded 140/90 mmHg on two consecutive days (home monitoring) and was confirmed at the study center, the patient was entered into the amlodipine treatment period (period 3). In period 3, all patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.\n\nPart 2: Eligible patients randomized to part 2 received amlodipine 5 mg o.d. and aliskiren placebo for 12 weeks', 'interventionNames': ['Drug: Amlodipine', 'Drug: Placebo of Aliskiren']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'otherNames': ['SPP100'], 'description': '300 mg tablet once daily', 'armGroupLabels': ['Aliskiren']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': '5 mg capsule once daily', 'armGroupLabels': ['Amlodipine']}, {'name': 'Placebo of Aliskiren', 'type': 'DRUG', 'description': 'Matching placebo of aliskiren 300 mg tablet', 'armGroupLabels': ['Aliskiren', 'Amlodipine']}, {'name': 'Placebo of amlodipine', 'type': 'DRUG', 'description': 'Matching placebo of amlodipine 5 mg capsule', 'armGroupLabels': ['Aliskiren']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13125', 'city': 'Buch', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.6347, 'lon': 13.49679}}, {'zip': '30159', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigative site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}