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Food and Drug Administration


Cardiovascular and Renal Drugs Advisory Committee

Hilton Washington DC North/Gaithersburg

Gaithersburg Maryland


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.
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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