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The efficacy and safety of azilsartan medoxomil ( AZL ‐M) were evaluated in African‐American patients with hypertension in a 6‐week, double‐blind, randomized, placebo‐controlled trial, for which the primary end point was change from baseline in 24‐hour mean systolic blood pressure ( BP ). There were 413 patients, with a mean age of 52 years, 57% women, and baseline 24‐hour  BP  of 146/91 mm Hg. Treatment differences in 24‐hour systolic  BP  between  AZL ‐M 40 mg and placebo (−5.0 mm Hg; 95% confidence interval, −8.0 to −2.0) and  AZL ‐M 80 mg and placebo (−7.8 mm Hg; 95% confidence interval, −10.7 to −4.9) were significant ( P ≤.001 vs placebo for both comparisons). Changes in the clinic  BP s were similar to the ambulatory  BP  results. Incidence rates of adverse events were comparable among the treatment groups, including those of a serious nature. In African‐American patients with hypertension,  AZL ‐M significantly reduced ambulatory and clinic  BP s in a dose‐dependent manner and was well tolerated.

Evaluation of the angiotensin II receptor blocker azilsartan medoxomil in African‐American patients with hypertension