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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

n in New York in May 2010. The 10-week, randomized, double-blind study compared the effect of CLD and HCTZ, both in combination with azilsartan medoxomil, on systolic and diastolic blood pressure (SBP, DBP) by clinic blood pressure measurement and by ambulatory blood pressure monitoring (ABPM) in 609 patients with hypertension.

About HypertensionHypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation’s health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

About Fixed-Dose Combination of Azilsartan Medoxomil Plus ChlorthalidoneDeveloped by Takeda, azilsartan medoxomil plus chlorthalidone is an investigational fixed-dose combination for the treatment of hypertension, or high blood pressure. The fixed-dose combination of azilsartan medoxomil plus chlorthalidone contains two medications, azilsartan medoxomil, an angiotensin II receptor blocker, and chlorthalidone, a long-acting thiazide-like diuretic used in the treatment of hypertension. The most commonly reported adverse drug reactions occurring in at least two percent of azilsartan medoxomil plus CLD-treated patients at the recommended doses and greater than azilsartan medoxomil or chlorthalidone monotherapies were increased blood creatinine (11%), diz
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SOURCE Takeda Global Research & Development Center, Inc., U.S.
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