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Takeda Submits New Drug Application in the U.S. for Azilsartan Medoxomil Plus Chlorthalidone, an Investigational Fixed-Dose Combination for the Treatment of Hypertension
Date:2/23/2011

DEERFIELD, Ill. and OSAKA, Japan, February 23, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. U.S., submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) for the treatment of hypertension, or high blood pressure. Discovered by Takeda, azilsartan medoxomil is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Chlorthalidone is a long-acting oral thiazide-like diuretic used in the treatment of hypertension. The NDA submission was supported by four phase 3 clinical trials involving more than 4,000 patients with hypertension.

“Millions of patients with hypertension do not have their condition under control,” said Darryl Sleep, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc. U.S. “We believe this compound, the first in the U.S. to combine an ARB with chlorthalidone, could potentially provide an important new treatment option for patients with hypertension and the health care providers who manage them.”

In a phase 3 clinical trial, azilsartan medoxomil (20 mg/day, 40 mg/day and 80 mg/day), combined in a fixed-dose with CLD (12.5 mg/day and 25 mg/day), was studied versus azilsartan medoxomil and CLD monotherapies. In other studies, the fixed-dose combination of azilsartan medoxomil plus CLD was compared to azilsartan medoxomil coadministered with hydrochlorothiazide (HCTZ), another diuretic, and with a fixed-dose combination of olmesartan medoxomil and HCTZ.

Results from a phase 3 clinical trial of the fixed-dose combination of azilsartan medoxomil plus CLD were previously presented at the American Society of Hypertension, Inc. (ASH), 25th Annual Scientific Meeting and Expositio
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SOURCE Takeda Global Research & Development Center, Inc., U.S.
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