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ARTICLE | Clinical News

Azilsartan medoxomil/chlorthalidone: Phase III data

June 6, 2011 7:00 AM UTC

A double-blind, North American Phase III trial in 1,071 patients with moderate to severe hypertension showed that once-daily low- and high-dose combinations of azilsartan medoxomil/chlorthalidone each met the primary endpoint of significantly reducing mean trough sitting SBP from baseline to week 12 vs. a fixed-dose combination of olmesartan medoxomil/hydrochlorothiazide (42.5 and 44 mmHg, respectively, vs. 37.1 mmHg; p<0.001 for both). Additionally, low- and high-dose combinations of azilsartan medoxomil/chlorthalidone met the secondary endpoints of significantly reducing mean trough sitting SBP from baseline to week 4 (34.7 and 36.7 mmHg, respectively, vs. 29.7 mmHg; p<0.001 for both) and to week 8 vs. olmesartan medoxomil/hydrochlorothiazide (39.1 and 39.4 mmHg, respectively, vs. 33.5 mmHg; p<0.001 for both).

Patients receiving azilsartan medoxomil/chlorthalidone were force titrated from 20/12.5 and 40/12.5 mg doses to 40/12.5 and 80/12.5 mg doses at week 4, respectively, and to 40/25 and 80/25 mg doses at week 8, respectively. In the olmesartan medoxomil/hydrochlorothiazide arm, patients were force titrated from 20/12.5 mg to 40/12.5 mg at week 4 and to 40/25 mg at week 8. Data were presented at the American Society of Hypertension meeting in New York. ...