At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 enrolled
Drug / intervention
Azilsartan medoxomil and chlorthalidone +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.
A Randomized, Open-Label, Phase 3 Study to Compare Long-Term Safety and Tolerability of the TAK-491 and Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil and Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Subjects With Moderate Renal Impairment
In Brief
A Phase 3 clinical trial evaluating Azilsartan medoxomil and chlorthalidone and Olmesartan medoxomil and hydrochlorothiazide for Safety. Completed, enrolled 153 participants across 53 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with moderate renal impairment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety
CountriesBulgaria, Germany, Latvia, Lithuania, Netherlands, Poland, Slovakia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionOct 2012
TodayJul 2026
First PostedMar 7, 2011
Enrollment StartMar 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.3 years ago
Interventions
Azilsartan medoxomil and chlorthalidonedrug
Fixed-dose combination tablets.
Olmesartan medoxomil and hydrochlorothiazidedrug
Fixed-dose combination tablets.