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A Randomized, Open-Label, Phase 3 Study to Compare Long-Term Safety and Tolerability of the TAK-491 and Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil and Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Subjects With Moderate Renal Impairment
The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with moderate renal impairment.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 153 |
| Start date | 2011-03 |
| Completion | 2012-10 |
Conditions
- Safety
Interventions
- Azilsartan medoxomil and chlorthalidone
- Olmesartan medoxomil and hydrochlorothiazide
Primary outcomes
- Number of Participants With at Least 1 Adverse Event (AE) — From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open- label study drug (up to 56 weeks).
An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.
Countries
Bulgaria, Germany, Latvia, Lithuania, Netherlands, Poland, Slovakia, Ukraine