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The Impact of Azilsartan Medoxomil Treatment (Capsule Formulation) at Doses Ranging From 10 to 80 mg: Significant, Rapid Reductions in Clinic Diastolic and Systolic Blood Pressure

In this phase 2, multicenter, parallel‐group, double‐blind, dose‐ranging study, hypertensive adults (n=449) were randomized to receive one of five doses of a capsule formulation of azilsartan medoxomil (AZL‐M; 5, 10, 20, 40, 80 mg), olmesartan medoxomil (OLM) 20 mg, or placebo once daily. The primary endpoint was change in trough clinic diastolic blood pressure (DBP) at week 8. AZL‐M provided rapid statistically and clinically significant reductions in DBP and systolic blood pressure (SBP) vs placebo at all doses except 5 mg. Placebo‐subtracted changes were greatest with the 40 mg dose (DBP, −5.7 mm Hg; SBP, −12.3 mm Hg). Clinic changes with AZL‐M (all doses) were statistically indistinguishable vs OLM, although there were greater reductions with AZL‐M 40 mg using 24‐hour ambulatory blood pressure. Adverse event frequency was similar in the AZL‐M and placebo groups. Based on these and other findings, subsequent trials investigated the commercial AZL‐M tablet in the dose range of 20 to 80 mg/d.