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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT00091715

Run by

Actelion

People needed

185

Starts

2004-04-01

Expected to finish

2011-02-01

Last updated by the study team

2011-08-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• University of Alabama-Birmingham — Birmingham, Alabama, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• Tufts- New England Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• St. Paul University Hospital — Dallas, Texas, United States
• The Prince Charles Hospital — Brisbane, Australia
• Royal Prince Albert Hospital — Camperdown, Australia
• St. Vincent's Hospital — Darlinghurst, Australia
• General Hospital of Vienna — Vienna, Austria
• UZ Gasthuisberg — Leuven, Belgium
• University of Calgary — Calgary, Alberta, Canada
• University of Alberta — Edmonton, Alberta, Canada
• Halifax Infirmary — Halifax, Nova Scotia, Canada
• Victoria Medical Centre — Hamilton, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Centre de Pneumologie de L'Hospital Laval — Sainte-Foy, Quebec, Canada
• Queen Mary Hospital — Hong Kong, China
• Interni klinika VFN — Prague, Czechia
• Marseille-Timone — Marseille, France
• Universitat Greifswald — Greifswald, Germany
• Universitat Greifswald — Greifswald, Germany
• Universitarsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Medizinische Universitatsklinik — Heidelberg, Germany
• Universitatsklinikim Leipzig — Leipzig, Germany

Full record on ClinicalTrials.gov

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