Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT00706134
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2008-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
Sponsor:
Organization:
Raw JSON
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Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'End of study (week 8)', 'description': 'Population description of safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.', 'otherNumAtRisk': 186, 'otherNumAffected': 0, 'seriousNumAtRisk': 186, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.', 'otherNumAtRisk': 191, 'otherNumAffected': 0, 'seriousNumAtRisk': 191, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.', 'otherNumAtRisk': 189, 'otherNumAffected': 0, 'seriousNumAtRisk': 189, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.', 'otherNumAtRisk': 188, 'otherNumAffected': 0, 'seriousNumAtRisk': 188, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 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complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'OG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.97', 'spread': '1.043', 'groupId': 'OG000'}, {'value': '-12.51', 'spread': '1.024', 'groupId': 'OG001'}, {'value': '-15.28', 'spread': '1.035', 'groupId': 'OG002'}, {'value': '-14.14', 'spread': '1.042', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of study (Week 8)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'OG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.50', 'spread': '0.579', 'groupId': 'OG000'}, {'value': '-5.33', 'spread': '0.568', 'groupId': 'OG001'}, {'value': '-6.42', 'spread': '0.575', 'groupId': 'OG002'}, {'value': '-6.66', 'spread': '0.579', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of study (Week 8)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Systolic Blood Pressure Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'OG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '42.4', 'groupId': 'OG001'}, {'value': '44.1', 'groupId': 'OG002'}, {'value': '47.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Week 8)', 'description': 'Patients achieving a systolic blood pressure response had to have a msSBP \\< 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'OG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'classes': [{'title': 'Ambulatory Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.280', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '1.155', 'groupId': 'OG001'}, {'value': '-5.76', 'spread': '1.128', 'groupId': 'OG002'}, {'value': '-5.83', 'spread': '1.520', 'groupId': 'OG003'}]}]}, {'title': 'Ambulatory Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.990', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '0.877', 'groupId': 'OG001'}, {'value': '-3.26', 'spread': '0.693', 'groupId': 'OG002'}, {'value': '-2.45', 'spread': '0.823', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of study (Week 8)', 'description': 'Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.'}, {'type': 'SECONDARY', 'title': 'Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'OG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.089', 'groupId': 'OG002'}, {'value': '-0.51', 'spread': '0.096', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of study (Week 8)', 'description': 'Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.'}, {'type': 'SECONDARY', 'title': 'Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'OG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'OG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '1.782', 'groupId': 'OG000'}, {'value': '-3.04', 'spread': '1.596', 'groupId': 'OG001'}, {'value': '-7.03', 'spread': '1.539', 'groupId': 'OG002'}, {'value': '-3.96', 'spread': '1.660', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of study (week 8)', 'description': 'The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'FG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'FG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'FG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '189'}, {'groupId': 'FG003', 'numSubjects': '186'}]}, {'type': 'Entered Double-blind Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '189'}, {'groupId': 'FG003', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '173'}, {'groupId': 'FG002', 'numSubjects': '183'}, {'groupId': 'FG003', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Did not meet study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '756', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablet taken once daily in the morning with a light meal.'}, {'id': 'BG001', 'title': 'Aliskiren 75 mg', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'BG002', 'title': 'Aliskiren 150 mg', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'BG003', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥ 65 and < 75 years of age', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}, {'value': '517', 'groupId': 'BG004'}]}]}, {'title': '≥ 75 years of age', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '417', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '339', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 756}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-24', 'studyFirstSubmitDate': '2008-06-25', 'resultsFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-18', 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)', 'timeFrame': 'Baseline to end of study (Week 8)'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)', 'timeFrame': 'Baseline to end of study (Week 8)'}, {'measure': 'Percentage of Patients Achieving Systolic Blood Pressure Response', 'timeFrame': 'Baseline to end of study (Week 8)', 'description': 'Patients achieving a systolic blood pressure response had to have a msSBP \\< 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.'}, {'measure': 'Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study', 'timeFrame': 'Baseline to end of study (Week 8)', 'description': 'Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.'}, {'measure': 'Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)', 'timeFrame': 'Baseline to end of study (Week 8)', 'description': 'Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.'}, {'measure': 'Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)', 'timeFrame': 'Baseline to end of study (week 8)', 'description': 'The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', '≥ 65 years', 'aliskiren', 'placebo', 'light meal'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients 65 years of age and older.\n* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).\n* At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and \\< 180 mmHg (msDBP \\<110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.\n\nExclusion Criteria:\n\n* Severe hypertension \\[Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg\\].\n* History or evidence of a secondary form of hypertension.\n* Known Keith-Wagener grade III or IV hypertensive retinopathy.\n* History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).\n* Current diagnosis of heart failure (NYHA Class II-IV).\n* History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).\n* Current angina pectoris requiring pharmacological therapy other than nitrates.\n\nOther protocol-defined inclusion/exclusion criteria applied to the study.'}, 'identificationModule': {'nctId': 'NCT00706134', 'briefTitle': 'Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal', 'orgStudyIdInfo': {'id': 'CSPP100A2405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren 75 mg', 'interventionNames': ['Drug: Aliskiren 75 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren 150 mg', 'interventionNames': ['Drug: Aliskiren 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren 300 mg', 'interventionNames': ['Drug: Aliskiren 300 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet taken once daily in the morning with a light meal.', 'armGroupLabels': ['Placebo']}, {'name': 'Aliskiren 75 mg', 'type': 'DRUG', 'description': 'Aliskiren 75 mg tablet taken once daily in the morning with a light meal.', 'armGroupLabels': ['Aliskiren 75 mg']}, {'name': 'Aliskiren 150 mg', 'type': 'DRUG', 'description': 'Aliskiren 150 mg tablet taken once daily in the morning with a light meal.', 'armGroupLabels': ['Aliskiren 150 mg']}, {'name': 'Aliskiren 300 mg', 'type': 'DRUG', 'description': 'Aliskiren 300 mg tablet taken once daily in the morning with a light meal.', 'armGroupLabels': ['Aliskiren 300 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigative Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'Investigative Site', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}