drugset / Trial / NCT00591253

Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension

NCT00591253 ↗

Phase 3 Completed 413 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.

Timeline

Start
2007-10
Primary completion
2009-04
Completion
2009-04

Outcome

Met primary endpoint

registry Azilsartan Medoxomil 40 mg QD vs Placebo QD; p = 0.001; Mean Difference (Final Values) -5.00 (95% CI -7.97 to -2.04) NCT00591253 ↗

registry Azilsartan Medoxomil 80 mg QD vs Placebo QD; p <0.001; Mean Difference (Final Values) -7.78 (95% CI -10.69 to -4.86) NCT00591253 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Azilsartan medoxomil Other / unclassified 40 mg Oral
Subject Azilsartan medoxomil Other / unclassified 80 mg Oral