Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension

Phase 3 Completed 551 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

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

Outcome

Met primary endpoint

registry Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD; p <0.001; Mean Difference (Final Values) -15.86 NCT00591773 ↗

registry Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD vs Chlorthalidone 25 mg QD; p <0.001; Mean Difference (Final Values) -15.45 NCT00591773 ↗

paper but greater than chlorthalidone alone (-15.9 (1.0) mmHg). PMID 30175930 ↗

Publications

Weber MA, Sever P, Juhasz A, Roberts A, Cao C. A randomized trial of the efficacy and safety of azilsartan medoxomil combined with chlorthalidone. J Renin Angiotensin Aldosterone Syst. 2018 Jul-Sep;19(3):1470320318795000. doi: 10.1177/1470320318795000.

Drugs

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