Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
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)
2 other identifiers
interventional
185
13 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2004
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2004
CompletedFirst Posted
Study publicly available on registry
September 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 30, 2011
August 1, 2011
2.6 years
September 16, 2004
August 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
exercise capacity
Baseline to end of study
cardiac hemodynamics
Baseline to end of study
Study Arms (2)
1
EXPERIMENTAL62.5 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.
2
PLACEBO COMPARATORplacebo for 6 months followed by an open label period
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (34)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
Harbor UCLA Medical Center
Torrance, California, 90509, United States
Tufts- New England Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
St. Paul University Hospital
Dallas, Texas, 75390, United States
The Prince Charles Hospital
Brisbane, 4032, Australia
Royal Prince Albert Hospital
Camperdown, Australia
St. Vincent's Hospital
Darlinghurst, Australia
General Hospital of Vienna
Vienna, 1180, Austria
UZ Gasthuisberg
Leuven, Belgium
University of Calgary
Calgary, Alberta, T1Y 6J4, Canada
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7, Canada
Victoria Medical Centre
Hamilton, Ontario, L8L 5G4, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Centre de Pneumologie de L'Hospital Laval
Sainte-Foy, Quebec, G1V 4G5, Canada
Queen Mary Hospital
Hong Kong, China
Interni klinika VFN
Prague, Czechia
Marseille-Timone
Marseille, 13005, France
Universitat Greifswald
Greifswald, 17487, 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, CB3 8RE, United Kingdom
Related Publications (1)
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.
PMID: 18572079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2004
First Posted
September 20, 2004
Study Start
April 1, 2004
Primary Completion
November 1, 2006
Study Completion
February 1, 2011
Last Updated
August 30, 2011
Record last verified: 2011-08