Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT00927394
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Directors', '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': 'Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.', 'otherNumAtRisk': 574, 'otherNumAffected': 34, 'seriousNumAtRisk': 574, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.', 'otherNumAtRisk': 565, 'otherNumAffected': 36, 'seriousNumAtRisk': 565, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sweat gland infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heat exhaustion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 565, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.3', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '14.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 8', 'description': "The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.7', 'spread': '18.70', 'groupId': 'OG000'}, {'value': '-18.2', 'spread': '18.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8', 'description': 'Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '8.80', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '8.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 8', 'description': "The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '8.58', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '8.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 8', 'description': 'The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '10.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8', 'description': 'Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.8', 'spread': '13.46', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '13.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 8', 'description': 'At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Blood pressure control was defined as MSSBP/MSDBP \\<140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': 'Responders were defined as patients with MSSBP \\<130 mmHg or a reduction from baseline in MSSBP of \\>20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Renin Activity (PRA) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.056', 'spread': '4.966', 'groupId': 'OG000'}, {'value': '0.879', 'spread': '4.646', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8', 'unitOfMeasure': 'ng/mL/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Renin Concentration (PRC) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.592', 'spread': '209.544', 'groupId': 'OG000'}, {'value': '124.721', 'spread': '489.719', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Aldosterone at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.957', 'spread': '115.251', 'groupId': 'OG000'}, {'value': '-22.562', 'spread': '123.343', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.\n\nSerious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set - Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'FG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '575'}, {'comment': 'One patient was randomized in error and was discontinued by site.', 'groupId': 'FG001', 'numSubjects': '568'}]}, {'type': 'Cohort 1 (Randomized)', 'achievements': [{'comment': 'Cohort 1 includes patients with specific eligibility criteria mentioned in protocol section', 'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'Cohort 2 (Randomized)', 'achievements': [{'comment': 'Cohort 2 includes patients with specific eligibility criteria mentioned in protocol section', 'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '403'}]}, {'type': 'Combined Safety Set (Cohort 1 and 2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '574'}, {'groupId': 'FG001', 'numSubjects': '565'}]}, {'type': 'Cohort 1: Full Analysis Set 1 (FAS 1)', 'achievements': [{'comment': 'FAS 1 includes all patients in Cohort 1 to whom study treatments were given through randomization.', 'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'Cohort 2: Full Analysis Set 2 (FAS 2)', 'achievements': [{'comment': 'FAS 2= all patients randomized to Cohort 2 and who had a valid baseline assessment of 24 hours ABPM.', 'groupId': 'FG000', 'numSubjects': '417'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'FAS 2 :Ambulatory Blood Pressure Monitor', 'achievements': [{'comment': 'consists of all patients in FAS 2 who had both valid baseline and post-baseline ABPM assessments.', 'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '323'}]}, {'type': 'Combined Full Analysis Set (FAS 1+FAS 2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '574'}, {'groupId': 'FG001', 'numSubjects': '562'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '498'}, {'groupId': 'FG001', 'numSubjects': '483'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '85'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Administrative Problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Randomized in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '565', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks'}, {'id': 'BG001', 'title': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '55.2', 'spread': '9.60', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '9.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Demographic measures were based on Safety set.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-01', 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8', 'timeFrame': 'baseline, week 8', 'description': "The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)', 'timeFrame': 'Baseline, week 8', 'description': 'Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.'}, {'measure': 'Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8', 'timeFrame': 'baseline, week 8', 'description': "The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24."}, {'measure': 'Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8', 'timeFrame': 'baseline, week 8', 'description': 'The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.'}, {'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)', 'timeFrame': 'Baseline, week 8', 'description': 'Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.'}, {'measure': 'Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8', 'timeFrame': 'baseline, week 8', 'description': 'At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.'}, {'measure': 'Percentage of Patients Achieving Blood Pressure Control', 'timeFrame': '8 weeks', 'description': 'Blood pressure control was defined as MSSBP/MSDBP \\<140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported'}, {'measure': 'Percentage of Responders', 'timeFrame': 'Baseline, Week 8', 'description': 'Responders were defined as patients with MSSBP \\<130 mmHg or a reduction from baseline in MSSBP of \\>20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.'}, {'measure': 'Change From Baseline in Plasma Renin Activity (PRA) at Week 8', 'timeFrame': 'Baseline, week 8'}, {'measure': 'Change From Baseline in Plasma Renin Concentration (PRC) at Week 8', 'timeFrame': 'Baseline, week 8'}, {'measure': 'Change From Baseline in Plasma Aldosterone at Week 8', 'timeFrame': 'Baseline, week 8'}, {'measure': 'Number of Patients With Adverse Events, Serious Adverse Events and Death', 'timeFrame': '8 weeks', 'description': 'Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.\n\nSerious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.'}]}, 'conditionsModule': {'keywords': ['Hypertension, Type II Diabetes, Aliskiren, Valsartan,', 'Systolic blood pressure, Diastolic blood pressure,', 'Stage II, Combination'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '23339726', 'type': 'DERIVED', 'citation': 'Bakris GL, Oparil S, Purkayastha D, Yadao AM, Alessi T, Sowers JR. Randomized study of antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan monotherapy in hypertensive participants with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2013 Feb;15(2):92-100. doi: 10.1111/jch.12032. Epub 2012 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.', 'detailedDescription': 'When protocol Amendment 2 was released, there were patients who had already been randomized into the study. These patients were included in the trial prior to making changes to the eligibility criteria. Thus, the study contains 2 distinct cohorts. Cohort 1 contains those patients who had already been randomized, and had been deemed eligible based on the original inclusion/exclusion criteria, prior to Amendment 2. No new patients were randomized to Cohort 1. Cohort 2 contains patients who were randomized, having been found eligible based on the revised inclusion/exclusion criteria, after Amendment 2. Differences in the inclusion and exclusion criteria are indicated below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.\n* Men or women 18 years and older.\n* Patients with Type 2 diabetes mellitus with an HbA1c ≤ 9 % at visit 1 and on a stable anti-diabetic regimen not including insulin or stable diet and exercise for at least 4 weeks prior to visit 1.\n\nCohort 1:\n\n* Patients with Stage 2 systolic hypertension, defined as having a MSSBP ≥160 mmHg and \\<200 mmHg at Visit 5 (randomization).\n* Patients who have been newly diagnosed with hypertension or who have not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have MSSBP ≥ 160 mmHg and \\< 200 mmHg at Visit 1, otherwise, they will be considered screen failures.\n* Patients receiving antihypertensive medication must have a MSSBP of ≥150 mmHg and \\<200 mmHg at Study Visit 1, otherwise they will be considered screen failures.\n\nCohort 2:\n\n* Patients must also have had a mean 8-hour daytime ambulatory systolic blood pressure (ASBP) ≥140 mmHg AND mean 8-hour daytime ambulatory diastolic blood pressure (ADBP) ≥90 mmHg at Visit 5 (randomization).\n* Hypertensive patients with MSSBP ≥150 mmHg and but \\<200 mmHg AND MSDBP ≥95 but \\<120 mmHg at Visit 5 (randomization).\n* Patients who had been newly diagnosed with hypertension or who had not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have had MSSBP ≥150 mmHg but \\<200 mmHg and MSDBP ≥95 but \\<120 mmHg at Visit 1, otherwise, they were considered screen failures.\n\nExclusion Criteria:\n\n* Office blood pressure measured by cuff (MSSBP ≥200 mmHg or MSDBP ≥120 mmHg).\n* History or evidence of secondary hypertension of any etiology.\n* Refractory hypertension, defined as having uncontrolled BP (≥140/90 mmHg) while receiving 3 antihypertensive medications at the maximum approved dose of each drug, one of which must be a diuretic.\n* Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).\n* Type 2 diabetes mellitus currently requiring insulin treatment.\n* modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73m2\n* Serum sodium less than lower limit of normal, serum potassium \\< 3.5 mEq/L or ≥ 5.3 mEq/L at Visit 1.\n* Known Keith-Wagener grade III or IV hypertensive retinopathy.\n\nCohort 1:\n\n\\- Patients with known diabetic retinopathy (eg, having a history of laser therapy for diabetic retinopathy) or diabetic neuropathy (eg, receiving medication for diabetic neuropathy).\n\nCohort 2:\n\n\\- Patients with known diabetic retinopathy or diabetic neuropathy and/or having a history of treatment for either.\n\nOther protocol-defined inclusion/exclusion criteria applied.'}, 'identificationModule': {'nctId': 'NCT00927394', 'acronym': 'ViVID', 'briefTitle': 'Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CSPV100AUS02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Therapy: Aliskiren + Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks', 'interventionNames': ['Drug: Aliskiren', 'Drug: Valsartan', 'Drug: Placebo for Aliskiren', 'Drug: Placebo for Valsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monotherapy: Valsartan', 'description': 'To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.', 'interventionNames': ['Drug: Valsartan', 'Drug: Placebo for Aliskiren', 'Drug: Placebo for Valsartan']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Aliskiren 150 mg tablet', 'armGroupLabels': ['Combination Therapy: Aliskiren + Valsartan']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': 'Valsartan 160 mg capsules', 'armGroupLabels': ['Combination Therapy: Aliskiren + Valsartan', 'Monotherapy: Valsartan']}, {'name': 'Placebo for Aliskiren', 'type': 'DRUG', 'description': 'Placebo for Aliskiren 150 mg tablets', 'armGroupLabels': ['Combination Therapy: Aliskiren + Valsartan', 'Monotherapy: Valsartan']}, {'name': 'Placebo for Valsartan', 'type': 'DRUG', 'description': 'Placebo for Valsartan 160 mg capsules', 'armGroupLabels': ['Combination Therapy: Aliskiren + Valsartan', 'Monotherapy: Valsartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'USA', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}