TGRD presents positive results from Phase 3 studies of azilsartan medoxomil for lowering SBP at 25th ASH

Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) today announced results from pivotal phase 3 studies of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), demonstrating greater 24-hour systolic blood pressure (SBP) reduction compared to commonly prescribed ARBs olmesartan medoxomil and valsartan. Results were statistically significant and showed that azilsartan medoxomil (80 mg/day) lowered 24-hour SBP by Ambulatory Blood Pressure Monitoring (ABPM), the primary endpoint, in head-to-head trials with the highest approved doses of olmesartan medoxomil and valsartan in hypertensive patients. The studies were presented today at the American Society of Hypertension, Inc. (ASH) 25th Annual Scientific Meeting and Exposition in New York.  

"We were encouraged at the results demonstrating azilsartan medoxomil achieved greater reductions in 24-hour mean systolic blood pressure when compared to two other commonly used ARBs at their respective maximum doses," said Stuart Kupfer, M.D., executive medical director, Takeda clinical science. "Having new treatment options is important to potentially address the estimated 42 million hypertensive patients in the United States who may not be adequately controlled and are at risk for other serious health problems."

The azilsartan medoxomil NDA was submitted in April 2010 and was supported by seven phase 3 clinical trials involving more than 5,900 patients.