Pulmonary Hypertension Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)
| Verified date | August 2011 |
| Source | Actelion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 185 |
| Est. completion date | February 2011 |
| Est. primary completion date | November 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Prince Charles Hospital | Brisbane | |
| Australia | Royal Prince Albert Hospital | Camperdown | |
| Australia | St. Vincent's Hospital | Darlinghurst | |
| Austria | General Hospital of Vienna | Vienna | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Canada | University of Calgary | Calgary | Alberta |
| Canada | University of Alberta | Edmonton | Alberta |
| Canada | Halifax Infirmary | Halifax | Nova Scotia |
| Canada | Victoria Medical Centre | Hamilton | Ontario |
| Canada | Centre de Pneumologie de L'Hospital Laval | Sainte Foy | Quebec |
| Canada | Toronto General Hospital | Toronto | Ontario |
| China | Queen Mary Hospital | Hong Kong | |
| Czech Republic | Interni klinika VFN | Prague | |
| France | Marseille-Timone | Marseille | |
| Germany | Universitat Greifswald | Greifswald | |
| Germany | Universitat Greifswald | Greifswald | |
| Germany | Universitarsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Medizinische Universitatsklinik | Heidelberg | |
| Germany | Universitatsklinikim Leipzig | Leipzig | |
| Germany | Klinikum der Universitat Regensburg | Regensburg | |
| Italy | Policlinico S. Orsola-Malpighi | Bologna | |
| Netherlands | VU Medisch Centrum | Amsterdam | |
| Netherlands | University Hospital Maastricht | Maastricht | |
| Spain | Hospital Clinic | Barcelona | |
| Spain | Hospital Valle d'Hebron | Barcelona | |
| Spain | Hospital 12 de Octubre | Madrid | |
| Switzerland | Zurich University Hospital | Zurich | |
| United Kingdom | Papworth Hospital | Cambridge | |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | University of Alabama-Birmingham | Birmingham | Alabama |
| United States | Tufts- New England Medical Center | Boston | Massachusetts |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | St. Paul University Hospital | Dallas | Texas |
| United States | Harbor UCLA Medical Center | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Actelion |
United States, Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | exercise capacity | Baseline to end of study | No | |
| Primary | cardiac hemodynamics | Baseline to end of study | No |
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