Trial Information

Summary: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
[PIPF-004]

The purpose of this study is to measure the safety and effectiveness of two different doses (2403mg and 1197 mg) of pirfenidone as compared to placebo in patients with (Idiopathic Pulmonary Fibrosis) IPF. Placebo is a capsule that looks identical to pirfenidone but contains no active medicine. Participation will include 13 visits to the clinic over a 60 week period (about 1 year). All study medications and procedures will be provided at no cost.


No Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible to participate if you:
-are a male or female between 40 to 80 years old
-have symptoms of Idiopathic Pulmonary Fibrosis
-meet additional criteria

You will not be able to participate if you:
-have ever used pirfenidone
-have a history of drug or alcohol abuse in the past 2 years
-are pregnant or breastfeeding

Contact:

Adriana Rodriguez, Clinical Research Coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Telephone: 212-241-5137
Fax: 212-831-3560
Email:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: June 1, 2008 at 6:45:16 AM


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