At a glance
ClinicalIndex Comparison Record- ✓Mean sitting clinic systolic BP 160-190 mm Hg, either after washout from current antihypertensive therapy or without antihypertensive treatment within 28 days before screening and at both screening visit and day prior to randomization
- ✓Clinical laboratory test results within reference range or not clinically significant per investigator
- ✓Willing to discontinue current antihypertensive medications by Day -21 (or Day -28 if on amlodipine or chlorthalidone)
- ✕Mean sitting clinic diastolic BP >119 mm Hg on day prior to randomization
- ✕Secondary hypertension of any etiology
- ✕Recent history of myocardial infarction, heart failure, unstable angina, CABG, PCI, hypertensive encephalopathy, stroke, or TIA
- ✕Clinically significant cardiac conduction defects
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Participants With Moderate to Severe Hypertension
In Brief
A Phase 3 clinical trial evaluating Azilsartan medoxomil and chlorthalidone, Chlorthalidone, and 1 other intervention for Hypertension. Completed, enrolled 1,711 participants across 99 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe hypertension.
Study Details
Timeline
Interventions
Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks