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An 8 Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension (ATLAAST)
The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 332 |
| Start date | 2008-07 |
| Completion | 2009-03 |
Conditions
- Hypertension
Interventions
- Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks
- Amlodipine: 8 weeks
Primary outcomes
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment — Baseline and 8 weeks
To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.
Countries
United States