ARTICLE | Clinical News

BiDil regulatory update

March 12, 2001 8:00 AM UTC

The FDA asked NitroMed to run a confirmatory study of its BiDil combination of hydralazine hydrochloride and isosorbide dinitrate to treat congestive heart failure (CHF) in African-Americans, in order to support approval of the BiDil NDA. The 600-patient placebo-controlled U.S. study will compare BiDil to standard therapy on the composite primary end point of quality of life, hospitalization and mortality. The study is expected to last about a year. ...