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A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension (ACQUIRE)
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 688 |
| Start date | 2008-06 |
| Completion | 2009-04 |
Conditions
- Hypertension
Interventions
- Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
- Aliskiren (300 mg)
Primary outcomes
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12) — Baseline to end of study (Week 12)
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Countries
United States, Argentina, Ecuador, Germany, Guatemala, Italy, Switzerland, Turkey (Türkiye)