Food and Drug
Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
(CDER)
Cardiovascular and Renal Drugs Advisory
Committee
Hilton Washington
DC North/Gaithersburg
Gaithersburg
Maryland
SLIDES
April 26, 2006
1:00
P.M. – 5:00 P.M.
The
committee will discuss the safety implications for the use
of placebo in studies of drugs to treat antihypertension.
The largest database is from the “Placebo in Hypertension
Adverse Reaction Meta-Analysis” (PHARM) Study, a meta-analysis
of more than 80,000 patients in placebo-controlled trials
of antihypertensive medication submitted in NDAs
FDA Presentation
Placebo-Controls
in Short-Term
Clinical Trials of Hypertension
(ppt) (htm) |
Sana
M. Al-Khatib, M.D., M.H.S.
Electrophysiologist
Electrophysiologist
Department of Medicine
– Division of Cardiology
Duke
University
Medical Center
|
A Report on the PHARM Study
(ppt)
(htm) |
Raymond Lipicky, M.D. Principal Investigator
Lipicky Consulting
|
Serious Clinical Events
in the PHARM Study
(ppt) (htm) |
Dennis Mangano,
Ph.D., M.D.
Principal Scientist/Founder/CEO
Ischemia Research and Education Foundation |
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