CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 566 enrolled
Drug / intervention
Azilsartan Medoxomil and amlodipine +2 moredrug
Likely dose
Azilsartan Medoxomil and amlodipine 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/NCT00591266
NCT00591266Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Amlodipine 5 mg in Subjects With Essential Hypertension

Takeda·interventional·Posted Jan 11, 2008·Updated Jul 22, 2011

In Brief

A Phase 3 clinical trial evaluating Azilsartan Medoxomil and amlodipine and Amlodipine for Hypertension. Completed, enrolled 566 participants across 50 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.5 years ago

Interventions

Azilsartan Medoxomil and amlodipinedrug

Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.

Azilsartan Medoxomil and amlodipinedrug

Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.

Amlodipinedrug

Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.