A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study Comparing the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs Benicar HCT® (Olmesartan Medoxomil-Hydrochlorothiazide) in Subjects With Moderate to Severe Essential Hypertension

NCT00846365 Phase 3 COMPLETED Results posted

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe essential hypertension.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	1085
Start date	2009-03
Completion	2010-06

Conditions

• Essential Hypertension

Interventions

• Azilsartan medoxomil and chlorthalidone
• Azilsartan medoxomil and chlorthalidone
• Olmesartan medoxomil-hydrochlorothiazide

Primary outcomes

• Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure. — Baseline and Week 8.
  The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.

Countries

United States, Chile, Mexico