Who is sponsoring NCT02203916?

NCT02203916 is sponsored by Takeda.

What condition does NCT02203916 study?

NCT02203916 studies Hypertension.

What drugs are being tested in NCT02203916?

Interventions: Azilsartan medoxomil, Azilsartan medoxomil placebo.

What is the status of NCT02203916?

NCT02203916 is currently COMPLETED.

Last reviewed 2016-10-25 · How we verify

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension

NCT02203916 Phase 3 COMPLETED Results posted

The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil versus placebo in Korean adults with essential hypertension.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	328
Start date	2014-07
Completion	2016-02

Conditions

Hypertension

Interventions

Azilsartan medoxomil
Azilsartan medoxomil placebo

Primary outcomes

Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP) — Baseline and Week 6
The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.

Countries

South Korea