CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 984 enrolled
Drug / intervention
Azilsartan Medoxomil +2 moredrug
Likely dose
Azilsartan Medoxomil 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00591578
NCT00591578Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension

Takeda·interventional·Posted Jan 11, 2008·Updated Feb 2, 2012

In Brief

A Phase 3 clinical trial evaluating Azilsartan Medoxomil and Valsartan for Hypertension. Completed, enrolled 984 participants across 88 sites in 4 countries.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan in participants with essential hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesChile, Mexico, Peru, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.5 years ago

Interventions

Azilsartan Medoxomildrug

Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.

Azilsartan Medoxomildrug

Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.

Valsartandrug

Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.