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FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Date:12/20/2011

lood pressure goals."

Takeda Global Research & Development Center, Inc. U.S. submitted the new drug application for EDARBYCLOR in February 2011. The overall clinical program consisted of five phase 3 clinical studies involving more than 5,000 patients with hypertension. The studies, evaluating the safety and efficacy of EDARBYCLOR, ranged from eight weeks to 52 weeks in duration, with doses of azilsartan medoxomil/chlorthalidone ranging from 20/12.5 to 80/25 mg once daily. The studies demonstrated EDARBYCLOR:

  • Lowered mean trough (22-24 hours) systolic blood pressure (SBP) by Ambulatory Blood Pressure Monitoring significantly more than either azilsartan medoxomil or chlorthalidone alone
  • Lowered blood pressure in black and non-black patients at similar levels
  • Lowered clinic SBP significantly more than the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its highest approved dose (40/25 mg doses for both medications)

The most common adverse reactions seen in clinical studies were dizziness and fatigue.

"In clinical studies, EDARBYCLOR demonstrated statistically significant blood pressure reductions compared to its respective monotherapies and was shown to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses," said Paulos Berhanu, M.D., executive medical director of medical & scientific affairs at Takeda. "It is our belief this innovative treatment helps reinforce Takeda's family of cardiovascular therapies by providing a new option to help appropriate patients, regardless of age, gender or race, work toward reaching their blood pressure goals."

About Hypertension
Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic and/or 90 mm Hg or greater diastolic. Elevated systolic or di
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SOURCE Takeda Pharmaceuticals North America, Inc.
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