Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.

Summary

The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe hypertension.

Timeline

Start

2010-01

Primary completion

2010-10

Completion

2010-11

Outcome

Met primary endpoint

registry p <0.001; Mean Difference (Final Values) -5.3 (95% CI -7.6 to -3.1) NCT01033071 ↗

registry p <0.001; Mean Difference (Final Values) -6.9 (95% CI -9.2 to -4.6) NCT01033071 ↗

paper Changes in clinic (primary end point) and ambulatory systolic blood pressures at week 12 were significantly greater in both azilsartan medoxomil/chlorthalidone arms than in the olmesartan/hydrochlorothiazide arm (P<0.001). PMID 22710649 ↗

Publications

• Cushman WC, Bakris GL, White WB, Weber MA, Sica D, Roberts A, Lloyd E, Kupfer S. Azilsartan medoxomil plus chlorthalidone reduces blood pressure more effectively than olmesartan plus hydrochlorothiazide in stage 2 systolic hypertension. Hypertension. 2012 Aug;60(2):310-8. doi: 10.1161/HYPERTENSIONAHA.111.188284. Epub 2012 Jun 18.

Drugs

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

Indications