CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 507 enrolled
Drug / intervention
Azilsartan medoxomil/placebo +1 moredrug
Likely dose
Not stated in 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/NCT01456169
NCT01456169Phase 3Completed
CompareCT.gov

A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy

Takeda·interventional·Posted Oct 20, 2011·Updated Apr 23, 2014

In Brief

A Phase 3 clinical trial evaluating Azilsartan medoxomil/placebo and Azilsartan medoxomil - chlorthalidone for Essential Hypertension. Completed, enrolled 507 participants across 108 sites in 14 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
CountriesBulgaria, Estonia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.7 years ago

Interventions

Azilsartan medoxomil/placebodrug

Azilsartan medoxomil and placebo to chlorthalidone combination tablets

Azilsartan medoxomil - chlorthalidonedrug

Azilsartan medoxomil and chlorthalidone fixed dose combination tablets