An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.

Phase 3 Completed 1291 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2008-04
Primary completion: 2009-08
Completion: 2009-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Azilsartan Medoxomil 80 mg QD vs Placebo QD; p <0.001; Mean Difference (Final Values) -14.27 (95% CI -16.54 to -12.01) NCT00696436 ↗

paper Azilsartan medoxomil at 80 mg had superior efficacy to both valsartan at 320 mg and olmesartan at 40 mg: PMID 21282560 ↗

paper Azilsartan medoxomil at 40 mg was noninferior to 40 mg of olmesartan (difference: -1.4 mm Hg [95% CI: -3.3 to 0.5]). PMID 21282560 ↗

Publications

Results White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011 Mar;57(3):413-20. doi: 10.1161/HYPERTENSIONAHA.110.163402. Epub 2011 Jan 31.

Drugs

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