A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

Phase 3 Completed 418 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension.

Timeline

Start: 2007-06
Primary completion: 2009-04
Completion: 2009-04

Outcome

Met primary endpoint

registry p <0.001; Mean Difference (Final Values) -7.78 (95% CI -9.78 to -5.78) NCT00696384 ↗

paper Mean DBP was maintained through the reversal phase in patients receiving AZL-M, but increased with placebo (difference: -7.8 mm Hg, 95% confidence interval, -9.8 to -5.8; P<.001). PMID 25619410 ↗

Publications

Kipnes MS, Handley A, Lloyd E, Barger B, Roberts A. Safety, tolerability, and efficacy of azilsartan medoxomil with or without chlorthalidone during and after 8 months of treatment for hypertension. J Clin Hypertens (Greenwich). 2015 Mar;17(3):183-92. doi: 10.1111/jch.12474. Epub 2015 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan medoxomil	Other / unclassified	20 mg	Oral
Subject	Azilsartan medoxomil	Other / unclassified	40 mg	Oral
Subject	Azilsartan medoxomil	Other / unclassified	80 mg	Oral
Background	Chlorthalidone	Other / unclassified	25 mg	Oral