Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 12:43 AM
Study NCT ID:
NCT00402103
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2006-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aliskiren 150mg/ Amlodipine 5mg Alone', 'description': 'Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning', 'otherNumAtRisk': 556, 'otherNumAffected': 14, 'seriousNumAtRisk': 556, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aliskiren 300mg/ Amlodipine 10mg Alone', 'description': 'Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning', 'otherNumAtRisk': 546, 'otherNumAffected': 138, 'seriousNumAtRisk': 546, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Aliskiren 300mg/ Amlodipine 10mg/ HCTZ', 'description': 'Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning', 'otherNumAtRisk': 86, 'otherNumAffected': 21, 'seriousNumAtRisk': 86, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pubic rami fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 556, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 546, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Percentage of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 150mg/ Amlodipine 5mg Alone', 'description': 'Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning'}, {'id': 'OG001', 'title': 'Aliskiren 300mg/ Amlodipine 10mg Alone', 'description': 'Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning'}, {'id': 'OG002', 'title': 'Aliskiren 300mg/ Amlodipine 10mg/ HCTZ', 'description': 'Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}, {'value': '71.2', 'groupId': 'OG001'}, {'value': '57.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Population'}, {'type': 'SECONDARY', 'title': 'Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren and Amlodipine tablets once a day in the morning'}, {'id': 'OG001', 'title': 'Aliskiren/Amlodipine/HCTZ', 'description': 'Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning'}], 'classes': [{'title': 'Week 2 (Visit 5)', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '6.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visit 6)', 'categories': [{'measurements': [{'value': '-14.0', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '5.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (Visit 7)', 'categories': [{'measurements': [{'value': '-15.7', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '7.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (Visit 8)', 'categories': [{'measurements': [{'value': '-16.3', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '7.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (Visit 9)', 'categories': [{'measurements': [{'value': '-17.1', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '-13.1', 'spread': '7.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (Visit 10)', 'categories': [{'measurements': [{'value': '-16.7', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '8.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 41 (Visit 11)', 'categories': [{'measurements': [{'value': '-17.0', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '-15.4', 'spread': '6.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 (Visit 12)', 'categories': [{'measurements': [{'value': '-16.3', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '-15.3', 'spread': '6.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 (Visit 12) (LOCF)', 'categories': [{'measurements': [{'value': '-15.7', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '-14.2', 'spread': '7.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren and Amlodipine tablets once a day in the morning'}, {'id': 'OG001', 'title': 'Aliskiren/Amlodipine/HCTZ', 'description': 'Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning'}], 'classes': [{'title': 'Week 2 (Visit 5)', 'categories': [{'measurements': [{'value': '35.3', 'spread': '88.0', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (Visit 8)', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (Visit 10)', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '56.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 (Visit 12)', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 (Visit 12) (LOCF)', 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}, {'value': '58.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 10, Week 28 and Week 54', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren and Amlodipine tablets once a day in the morning'}, {'id': 'OG001', 'title': 'Aliskiren/Amlodipine/HCTZ', 'description': 'Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning'}], 'classes': [{'title': 'Week 2 (Visit 5)', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}, {'value': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (Visit 8)', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000'}, {'value': '61.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (Visit 10)', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}, {'value': '85.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 (Visit 12)', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '89.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 (Visit 12) (LOCF)', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000'}, {'value': '84.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 10, Week 28 and Week 54', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren and Amlodipine tablets once a day in the morning'}, {'id': 'FG001', 'title': 'Aliskiren/Amlodipine/HCTZ', 'description': 'Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '470'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Condition no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '556', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren/Amlodipine', 'description': 'Aliskiren and Amlodipine tablets once a day in the morning'}, {'id': 'BG001', 'title': 'Aliskiren/Amlodipine/HCTZ', 'description': 'Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '11.66', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '11.33', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '11.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 556}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-08', 'studyFirstSubmitDate': '2006-11-18', 'resultsFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2006-11-20', 'lastUpdatePostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-13', 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Percentage of Patients With Adverse Events', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54'}, {'measure': 'Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg', 'timeFrame': 'Baseline, Week 2, Week 10, Week 28 and Week 54'}, {'measure': 'Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline, Week 2, Week 10, Week 28 and Week 54'}]}, 'conditionsModule': {'keywords': ['Hypertension, aliskiren, amlodipine, HCTZ, blood pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '19257800', 'type': 'DERIVED', 'citation': 'Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.'}]}, 'descriptionModule': {'briefSummary': 'To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \\[msDBP\\] ≥ 90 mmHg and \\< 110 mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients 18 years of age or older\n* Male or female patients are eligible\n* For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \\< 110 mmHg at Visit 1 and Visit 4\n* For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \\< 110 mmHg after 2 to 4 weeks of washout (Visit 4)\n\nExclusion Criteria:\n\n* Severe hypertension\n* History or evidence of a secondary form of hypertension\n* History of Hypertensive encephalopathy or cerebrovascular accident.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00402103', 'briefTitle': 'An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'CSPA100A2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren/Amlodipine', 'interventionNames': ['Drug: Aliskiren', 'Drug: Amlodipine']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren/Amlodipine/HCTZ', 'interventionNames': ['Drug: Aliskiren', 'Drug: Amlodipine', 'Drug: Hydrochlorothiazide']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration', 'armGroupLabels': ['Aliskiren/Amlodipine', 'Aliskiren/Amlodipine/HCTZ']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration', 'armGroupLabels': ['Aliskiren/Amlodipine', 'Aliskiren/Amlodipine/HCTZ']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.', 'armGroupLabels': ['Aliskiren/Amlodipine/HCTZ']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}, {'city': 'Investigative Site', 'country': 'Belgium', 'facility': 'Investigator Site'}, {'city': 'Investigative Center', 'country': 'Denmark', 'facility': 'Investigative Center'}, {'city': 'Investigative Site', 'country': 'Finland', 'facility': 'Investigative Site'}, {'city': 'Investigative Center', 'country': 'Germany', 'facility': 'Investigative Center'}, {'city': 'Investigative Site', 'country': 'Iceland', 'facility': 'Investigative Site'}, {'city': 'Investigative Site', 'country': 'India', 'facility': 'Investigative Site'}, {'city': 'Investigative Site', 'country': 'Switzerland', 'facility': 'Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}