CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 669 enrolled
Drug / intervention
Azilsartan medoxomil with or without add-on chlorthalidone +1 moredrug
Likely dose
Azilsartan medoxomil with or without add-on chlorthalidone 40 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/NCT00695955
NCT00695955Phase 3Completed
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A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension

Takeda·interventional·Posted Jun 12, 2008·Updated Apr 19, 2011

In Brief

A Phase 3 clinical trial evaluating Azilsartan medoxomil with or without add-on chlorthalidone and Azilsartan medoxomil with or without add-on hydrochlorothiazide for Hypertension. Completed, enrolled 669 participants across 41 sites in 3 countries.

Detailed Summary

This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2008
Enrollment StartJun 1, 2007
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.1 years ago

Interventions

Azilsartan medoxomil with or without add-on chlorthalidonedrug

Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.

Azilsartan medoxomil with or without add-on hydrochlorothiazidedrug

Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.