Hypertension Clinical Trial
— ACCELERATEOfficial title:
A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
Status | Completed |
Enrollment | 1254 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female outpatients = 18 years of age - Participants with essential hypertension: - Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) = 150 mmHg and < 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.) - All participants must have a msSBP = 150 mmHg and < 180 mmHg at Visit 2 - Written informed consent to participate in this study prior to any study procedures Exclusion Criteria: - Severe hypertension - Pregnant or nursing (lactating) women - Pre-menopausal women not taking accepted form of birth control - Serum potassium = 5.5 mEq/L (mmol/L) at Visit 1 - History of cardiovascular conditions - Uncontrolled Type 1 or Type 2 diabetes mellitus - Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Investigative Site | Toronto | |
Costa Rica | Investigative Site | San Jose | |
France | Investigative Site | Paris | |
Germany | Investigative Site | Bonn | |
Greece | Investigative Site | Athens | |
Guatemala | Investigative Site | Guatemala city | |
South Africa | Investigative Site | Cape Town | |
Switzerland | Investigative Site | Basel | |
United Kingdom | Investigative Site | London | |
Venezuela | Investigative Site | Caracas |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Canada, Costa Rica, France, Germany, Greece, Guatemala, South Africa, Switzerland, United Kingdom, Venezuela,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks | Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate. | Baseline, 8 weeks, 16 weeks, and 24 weeks | No |
Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 | Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate. | Baseline to 24 weeks | No |
Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32 | Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate. | Baseline to 32 weeks | No |
Secondary | Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks | Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate. | Baseline, 8 weeks, 16 weeks and 24 weeks | No |
Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24 | Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate. | Baseline to 24 weeks | No |
Secondary | Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints | Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints. | Baseline to week 8, 16, 24 and 32 endpoints | No |
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