Positive results for Edarbyclor (Takeda) in Phase III study of Hypertension - 07-Sep-2012

Results of a 10-week, Phase III study of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, for patients with Hypertension found the clinic systolic blood pressure (SBP) reductions for Edarbyclor were significantly greater at six and ten weeks than those of azilsartan medoxomil co-administered with hydrochlorothiazide. Data also showed that more patients achieved their target blood pressure levels when taking the Edarbyclor fixed-dose combination at the end of both six weeks (64.1 percent vs. 45.9 percent) and 10 weeks (71.5 percent vs. 62.3 percent). Primary endpoint data showed that at week 6, the clinic SBP reductions of the fixed-dose Edarbyclor were -35.1 mm Hg. These data were statistically significantly (P<0.001) greater than those of Edarbyclor (-29.5 mm Hg). At the end of 10 weeks, greater clinic SBP reductions were maintained in patients taking the fixed-dose Edarbyclor (-37.8 mm Hg) versus those taking azilsartan medoxomil and hydrochlorothiazide (-32.8 mm Hg).

Edarbyclor was approved by the FDA in December 2011 for the treatment of Hypertension to lower blood pressure in adults. The results have been published online in the American Journal of Medicine. See: "Antihypertensive Efficacy of Hydrochlorothiazide Versus Chlorthalidone Combined With Azilsartan Medoxomil" George L. Bakris et al. American Journal of Medicine, Spetember 2012, doi:10.1016/j.amjmed.2012.05.023