Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease

Phase 3 Completed 153 enrolled Takeda

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with moderate renal impairment.

Timeline

Start: 2011-03
Primary completion: 2012-10
Completion: 2012-10

Publications

Bakris GL, Zhao L, Kupfer S, Juhasz A, Hisada M, Lloyd E, Oparil S. Long-term efficacy and tolerability of azilsartan medoxomil/chlorthalidone vs olmesartan medoxomil/hydrochlorothiazide in chronic kidney disease. J Clin Hypertens (Greenwich). 2018 Apr;20(4):694-702. doi: 10.1111/jch.13230. Epub 2018 Mar 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan medoxomil	Other / unclassified	40 mg	Oral
Subject	Chlorthalidone	Other / unclassified	25 mg	Oral
Comparator	Hydrochlorothiazide	Unknown	25 mg	Oral
Comparator	Olmesartan medoxomil	Unknown	20 mg	Oral
Comparator	Olmesartan medoxomil	Unknown	40 mg	Oral

Indications

No indication recorded.