NitroMed begins BiDil trial

NtroMed (Bedford, Mass.) began the African American Heart Failure Trial (A-HeFT), a 600-patient study designed to confirm the efficacy of BiDil, a combination of hydralazine hydrochloride and isosorbide dinitrate, to treat congestive heart failure in African American patients. Earlier this month, the FDA asked NitroMed to run a confirmatory study to support approval of the BiDil NDA (see BioCentury, Mar.12). The placebo-controlled U.S. study will compare BiDil to standard therapy on the composite primary end point of quality of life, hospitalization and mortality. ...