Who is sponsoring NCT00591266?

NCT00591266 is sponsored by Takeda.

What condition does NCT00591266 study?

NCT00591266 studies Hypertension.

What drugs are being tested in NCT00591266?

Interventions: Azilsartan Medoxomil and amlodipine, Azilsartan Medoxomil and amlodipine, Amlodipine.

What is the status of NCT00591266?

NCT00591266 is currently COMPLETED.

Last reviewed 2011-07-18 · How we verify

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Amlodipine 5 mg in Subjects With Essential Hypertension

NCT00591266 Phase 3 COMPLETED Results posted

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	566
Start date	2007-10
Completion	2009-04

Conditions

Hypertension

Interventions

Azilsartan Medoxomil and amlodipine
Azilsartan Medoxomil and amlodipine
Amlodipine

Primary outcomes

Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. — Baseline and Week 6.
The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

Countries

United States