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A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study of the TAK 491 Plus Chlorthalidone Fixed-Dose Combination Compared With TAK-491 and Hydrochlorothiazide Coadministration Therapy in Subjects With Moderate to Severe Essential Hypertension
The purpose of this study is to compare the antihypertensive effect of chlorthalidone vs hydrochlorothiazide when each is used with azilsartan medoxomil, once daily (QD), in participants with moderate to severe essential hypertension.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 609 |
| Start date | 2009-02 |
| Completion | 2009-11 |
Conditions
- Essential Hypertension
Interventions
- Azilsartan medoxomil and chlorthalidone
- Azilsartan medoxomil and hydrochlorothiazide
Primary outcomes
- Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure — Baseline, Week 6 and Week 10.
The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
Countries
United States, Russia