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A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy
The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 507 |
| Start date | 2011-10 |
| Completion | 2013-01 |
Conditions
- Essential Hypertension
Interventions
- Azilsartan medoxomil/placebo
- Azilsartan medoxomil - chlorthalidone
Primary outcomes
- Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure — Baseline (of the double-blind treatment period) and Week 8
The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Countries
Bulgaria, Estonia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain, Sweden, United Kingdom