Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension

Phase 3 Completed 984 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan in participants with essential hypertension.

Timeline

Start: 2007-12
Primary completion: 2009-09
Completion: 2010-03

Outcome

Met primary endpoint

registry Azilsartan Medoxomil 40 mg QD vs Valsartan 320 mg QD; p <0.001; Mean Difference (Final Values) -3.64 (95% CI -5.59 to -1.69) NCT00591578 ↗

registry Azilsartan Medoxomil 80 mg QD vs Valsartan 320 mg QD; p <0.001; Mean Difference (Final Values) -4.03 (95% CI -6.01 to -2.06) NCT00591578 ↗

paper AZL-M 40 mg and 80 mg lowered 24-hour mean systolic BP (-14.9 mm Hg and -15.3 mm Hg, respectively) more than VAL 320 mg PMID 21762358 ↗

Publications

Results Sica D, White WB, Weber MA, Bakris GL, Perez A, Cao C, Handley A, Kupfer S. Comparison of the novel angiotensin II receptor blocker azilsartan medoxomil vs valsartan by ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich). 2011 Jul;13(7):467-72. doi: 10.1111/j.1751-7176.2011.00482.x. Epub 2011 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan medoxomil	Other / unclassified	40 mg	Oral
Subject	Azilsartan medoxomil	Other / unclassified	80 mg	Oral
Comparator	Valsartan	Unknown	320 mg	Oral