At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo-Controlled, 5-Arm Titration Study to Evaluate the Efficacy and Safety of TAK-491 When Compared With Valsartan and Olmesartan in Subjects With Essential Hypertension
In Brief
A Phase 3 clinical trial evaluating Azilsartan medoxomil, Valsartan, and 2 other interventions for Hypertension. Completed, enrolled 1,291 participants across 131 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential hypertension.
Study Details
Timeline
Interventions
Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks. Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.
Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks. Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.
Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks. Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.
Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks. Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.
Matching placebo, orally, once daily for up to six weeks.