Cardiovascular and Renal Drugs Advisory Committee

Holiday Inn Gaithersburg

Two Montgomery Village Avenue, Gaithersburg, MD

June 16, 2005




The committee will discuss new drug applications (NDA) 20-727, proposed trade name BiDil® (hydralazine hydrochloride/isosorbide dinitrate) Tablets, (37.5 mg hydralazine hydrochloride/20 mg isosorbide dinitrate), NitroMed, Inc., proposed for the indication of heart failure, based on the results from the African American Heart Failure Trial (A-HeFT)




NitroMed Presentation         


                        BiDil®  (isosorbide dinitrate/                   Manual Worcel, M.D.

                        hydralazine HCl):  Regulatory                 Chief Medical Officer

                        Background and Introductions                NitroMed, Inc.

                        [HTML]          [PPT]  


                        V-HeFT I and V-HeFT II:                     Jay N. Cohn, M.D.

ISDN/HYD Effects in Black                 Professor

Patients                                                University of Minnesota

[HTML]          [PPT]  


A-HeFT:  Rationale, Design                   Anne Taylor, M.D.

And Demographics                                Professor         

[HTML]          [PPT]                           University of Minnesota


A-HeFT:  Outcomes                              Clyde Yancy, M.D.

                        [HTML]          [PPT]                           Professor

                                                                                    University of Texas Southwestern Medical School


                        Conclusions:  From V-HeFT I                Milton Packer, M.D.

                        To A-HeFT                                          Professor

                        [HTML]          [PPT]                           University of Texas Southwestern Medical School


                        Questions and Answers                         Michael Sabolinski, M.D.

                                                                                    Senior Vice President of Clinical Development and

                                                                                    Regulatory Affairs

                        [HTML]          [PPT]                           NitroMed, Inc.


                        Open Public Hearing Speakers

                        [HTML]          [PPT]  


                                                                                    Shomarka Omar Y. Keita, M.D., D.Phil.

                                                                                    Medical Officer

                                                                                    Department of Human Services, District of Columbia

                                                                                    Research Associate

                        [HTML]          [PPT]                           Anthropology Department, Smithsonian Institution


                                                                                    Basil Halliday, M.Sc.

                        [HTML]          [PPT]                           President & CEO - BDH Clinical Research Services


                                                                              Charles N. Rotimi, Ph.D.

                                                                                    National Human Genome Center

                        [HTML]          [PPT]                           Howard University


                                                                              Charmaine Royal, Ph.D.

                                                                                    National Human Genome Center

                        [HTML]          [PPT]                           Howard University



                        [HTML]          [PPT]