Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension

Phase 3 Completed 1085 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe essential hypertension.

Timeline

Start: 2009-03
Primary completion: 2010-06
Completion: 2010-06

Outcome

Met primary endpoint

paper observed (P < 0.001) in both AZL-M/CTD arms (-37.6 and -38.2 mmHg) versus OLM/HCTZ (-31.5 mmHg) PMID 29334491 ↗

registry p <0.001; Mean Difference (Final Values) -6.1 (95% CI -8.4 to -3.8) NCT00846365 ↗

registry p <0.001; Mean Difference (Final Values) -6.7 (95% CI -9.1 to -4.4) NCT00846365 ↗

Publications

Cushman WC, Bakris GL, White WB, Weber MA, Sica D, Roberts A, Lloyd E, Kupfer S. A randomized titrate-to-target study comparing fixed-dose combinations of azilsartan medoxomil and chlorthalidone with olmesartan and hydrochlorothiazide in stage-2 systolic hypertension. J Hypertens. 2018 Apr;36(4):947-956. doi: 10.1097/HJH.0000000000001647.

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