Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II

PHASE3CompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

November 30, 2006

Study Completion Date

February 28, 2011

Conditions
Pulmonary Hypertension
Interventions
DRUG

bosentan

65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study

DRUG

placebo

placebo for 6 months followed by an open-label period

Trial Locations (34)

1180

General Hospital of Vienna, Vienna

4032

The Prince Charles Hospital, Brisbane

13005

Marseille-Timone, Marseille

17487

Universitat Greifswald, Greifswald

35294

University of Alabama-Birmingham, Birmingham

44195

Cleveland Clinic Foundation, Cleveland

48109

University of Michigan, Ann Arbor

75390

St. Paul University Hospital, Dallas

90509

Harbor UCLA Medical Center, Torrance

02111

Tufts- New England Medical Center, Boston

Unknown

Royal Prince Albert Hospital, Camperdown

St. Vincent's Hospital, Darlinghurst

UZ Gasthuisberg, Leuven

Queen Mary Hospital, Hong Kong

Interni klinika VFN, Prague

Universitat Greifswald, Greifswald

Universitarsklinikum Hamburg-Eppendorf, Hamburg

Medizinische Universitatsklinik, Heidelberg

Universitatsklinikim Leipzig, Leipzig

Klinikum der Universitat Regensburg, Regensburg

Policlinico S. Orsola-Malpighi, Bologna

VU Medisch Centrum, Amsterdam

University Hospital Maastricht, Maastricht

Hospital Clinic, Barcelona

Hospital Valle d'Hebron, Barcelona

Hospital 12 de Octubre, Madrid

Zurich University Hospital, Zurich

T1Y 6J4

University of Calgary, Calgary

T6G 2B7

University of Alberta, Edmonton

B3H 3A7

Halifax Infirmary, Halifax

L8L 5G4

Victoria Medical Centre, Hamilton

M5G 2N2

Toronto General Hospital, Toronto

G1V 4G5

Centre de Pneumologie de L'Hospital Laval, Sainte-Foy

CB3 8RE

Papworth Hospital, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY