Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Cardiovascular and Renal Drugs Advisory Committee

98th Meeting

January 7, 2003

Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD


8:00 Call to Order and Opening Remarks Jeffrey Borer, M.D., Chair

Introduction of Committee

Conflict of Interest Statement Jayne E. Peterson, R.Ph., J.D., Acting Executive Secretary, FDA


sNDA 20-297/S-009, Coregâ (carvedilol), GlaxoSmithKline

Proposed to reduce mortality and the risk of infarction in clinically stable patients who

have survived the acute phase of a myocardial infarction and have a left ventricular

ejection fraction £ 40%.


8:15 Sponsor Presentation

Clare Kahn, Ph.D.
Vice President, U.S. Reg. Affairs
Cardiovascular, Urogenital &
Metabolic Products, GlaxoSmithKline

Background to the CAPRICORN Trial
Mary Ann Lukas, M.D.
Senior Clinical Director, GSK


Primary Endpoints Henry Dargie, M.D., Univ. of Glasgow

Principal Investigator, CAPRICORN

Why are We Here? Milton Packer, M.D., Columbia Univ.

Planning Committee, CAPRICORN

Principal Investigator, COPERNICUS

CAPRICORN Trial Henry Dargie, M.D.

Effect on Non-Fatal Events

Safety and Concluding Remarks Milton Packer, M.D.


Cardiovascular and Renal Drugs Advisory Committee

98th Meeting

January 7, 2003


AGENDA (cont.)

9:30 Committee Discussion and Review

Committee Reviewer: Marc Pfeffer, M.D., Ph.D.

10:30 Break

10:45 Continuation of Committee Discussion and Review

12:00 Lunch

1:00 Open Public Hearing

2:00 Continuation of Committee Discussion and Review

3:15 Break

3:30 Continuation of Committee Discussion and Review

4:30 Estimated Time of Adjournment

SGE Consultants (voting)

Thomas G. Pickering, M.D., DPhil
Professor of Medicine
Director, Integrative and Behavioral Cardiovascular Health Program
and Hypertension Section
Michael and Zena A. Wiener Cardiovascular Institute
Mount Sinai School of Medicine
One Gustave L. Levy Place
New York, New York 10029-6574

Marc Pfeffer, M.D., Ph.D.
Professor of Medicine, Harvard Medical School
Senior Physician, Brigham & Women’s Hospital
Cardiovascular Division
75 Francis Street
Boston, Massachusetts, 02115

Acting Industry Representative (non-voting)

John F. Neylan, M.D.
Vice President, Clinical Research and Development
Wyeth Research
500 Ariola Road
Collegeville, Pennsylvania 19426