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An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension (ASCENT)
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 412 |
| Start date | 2009-06 |
Conditions
- Hypertension
Interventions
- Aliskiren/Amlodipine
- Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
Primary outcomes
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 — Baseline and week 8
To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Countries
United States