Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

September 30, 2005

Study Completion Date

May 31, 2010

Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG

bosentan

"Initial dose: 62.5 mg b.i.d. for 4 weeks.~* Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated).~* body weight \< 40 kg (90 lb): 62.5 mg b.i.d."

DRUG

Placebo

"Initial dose: 62.5 mg b.i.d. for 4 weeks.~* Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated).~* body weight \< 40 kg (90 lb): 62.5 mg b.i.d."

Trial Locations (29)

15261

University of Pittsburgh, Pittsburgh

19104

University of Pennsylvania, Philadelphia

33136

Jackson Memorial Hospital, Miami

35294

University of Alabama at Birmingham - Pulmonary Division, Birmingham

37232

Vanderbilt University Medical Center, Nashville

38043

Médecine Spécialisée Aigüe - CHU Grenoble, Grenoble

48109

University of Michigan Health System - Division of Pulmonary & Critical Care Medicine, Ann Arbor

52242

University of Iowa Hospitals & Clinics - Department of Internal Medicine, Iowa City

53792

University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine, Madison

55905

Mayo Medical School - Mayo Clinic, Rochester

69000

Hôpital Louis Pradel, Lyon

77030

Baylor College of Medicine, Houston

80204

National Jewish Medical and Research Center, Denver

90024

David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine, Los Angeles

92103

UCSD Medical Center, San Diego

94143

University of California - Ambulatory Care Center, San Francisco

98195

University of Washington - Division of Pulmonary & Critical Care Medicine, Seattle

06520

Yale University School of Medicine, New Haven

V6Z 1Y6

University of British Columbia - St. Paul's Hospital, Vancouver

M4X 1W4

Rosedale Medical Center, Toronto

H2L 4M1

Notre-Dame Hospital - Clinique du Thorax, Montreal

Unknown

Hôpital Avicenne - Université de Paris, Bobigny

Abt. Pneumologie Medizinische Klinik Universitätsklinikum Freiburg, Freiburg im Breisgau

Klinik Löwenstein gGmbH, Löwenstein

Medizinische Klinik und Poliklinik I Klinikum der Universität München, München

Sheba Medical Center, Tel Litwinsky

Section of Respiratory Diseases - Policlinico Le Scotte - Siena University, Siena

Inselspital, Bern

Royal Brompton Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY