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NitroMed BiDil

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The African American Heart Failure Trial (A-HeFT), the first prospective trial conducted exclusively in black men and women with heart failure, begins. The double-blind, placebo-controlled study is randomizing patients to receive BiDil (hydralazine HCl and isosorbide) or placebo in addition to their standard therapy (ACE inhibitors, digitalis, diuretics and beta-blockers). The study, initiated March 17, will enroll 600 patients with moderate to severe heart failure and a reduced ejection fraction who had at least one hospitalization for heart failure in the preceding 12 months. NitroMed submitted a BiDil NDA for treatment of heart failure in African Americans in July 200
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