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

Phase 3

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: placebo; Drug: bosentan

• Registration Number: NCT00091715
• Lead Sponsor: Actelion

Brief Summary

The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-09-16
• Study First Submitted QC: 2004-09-17
• Study First Posted: 2004-09-20
• Primary Completion: 2006-11
• Study Completion: 2011-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• PAH NYHA Class II
• Significant elevation of mean pulmonary arterial pressure
• Significant elevation of pulmonary vascular resistance at rest
• Limited 6-minute walk distance

Exclusion Criteria

• PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
• Restrictive or obstructive lung disease
• Significant vasoreactivity
• Treatments for PAH (within 4 weeks of randomization)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo for 6 months followed by an open label period
1	bosentan	62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study.

Primary Outcome Measures

Name	Time	Method
exercise capacity	Baseline to end of study
cardiac hemodynamics	Baseline to end of study

Trial Locations

Locations (33)

General Hospital of Vienna; 🇦🇹 Vienna, Austria

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Centre de Pneumologie de L'Hospital Laval; 🇨🇦 Sainte Foy, Quebec, Canada

Interni klinika VFN; 🇨🇿 Prague, Czech Republic

VU Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Medizinische Universitatsklinik; 🇩🇪 Heidelberg, Germany

Papworth Hospital; 🇬🇧 Cambridge, United Kingdom

Universitarsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Hospital Clinic; 🇪🇸 Barcelona, Spain

Queen Mary Hospital; 🇨🇳 Hong Kong, China

Marseille-Timone; 🇫🇷 Marseille, France

Victoria Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

The Prince Charles Hospital; 🇦🇺 Brisbane, Australia

Hospital Valle d'Hebron; 🇪🇸 Barcelona, Spain

St. Vincent's Hospital; 🇦🇺 Darlinghurst, Australia

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Universitat Greifswald; 🇩🇪 Greifswald, Germany

Royal Prince Albert Hospital; 🇦🇺 Camperdown, Australia

Klinikum der Universitat Regensburg; 🇩🇪 Regensburg, Germany

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

Policlinico S. Orsola-Malpighi; 🇮🇹 Bologna, Italy

Universitatsklinikim Leipzig; 🇩🇪 Leipzig, Germany

Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States

Tufts- New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Paul University Hospital; 🇺🇸 Dallas, Texas, United States

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Zurich University Hospital; 🇨🇭 Zurich, Switzerland

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain