Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
NCT ID: NCT00091715
Last Updated: 2011-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
185 participants
INTERVENTIONAL
2004-04-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2
placebo for 6 months followed by an open label period
placebo
placebo for 6 months followed by an open-label period
1
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.
bosentan
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
Interventions
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bosentan
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
placebo
placebo for 6 months followed by an open-label period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Significant elevation of mean pulmonary arterial pressure
* Significant elevation of pulmonary vascular resistance at rest
* Limited 6-minute walk distance
Exclusion Criteria
* Restrictive or obstructive lung disease
* Significant vasoreactivity
* Treatments for PAH (within 4 weeks of randomization)
12 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Locations
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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
Klinikum der Universitat Regensburg
Regensburg, , Germany
Policlinico S. Orsola-Malpighi
Bologna, , Italy
VU Medisch Centrum
Amsterdam, , Netherlands
University Hospital Maastricht
Maastricht, , Netherlands
Hospital Clinic
Barcelona, , Spain
Hospital Valle d'Hebron
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Zurich University Hospital
Zurich, , Switzerland
Papworth Hospital
Cambridge, , United Kingdom
Countries
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References
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Galie N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8.
Other Identifiers
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AC-052-364
Identifier Type: -
Identifier Source: secondary_id
EARLY
Identifier Type: -
Identifier Source: org_study_id
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