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

August 26, 2011 updated by: Actelion

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4032
        • The Prince Charles Hospital
      • Camperdown, Australia
        • Royal Prince Albert Hospital
      • Darlinghurst, Australia
        • St. Vincent's Hospital
  • Austria
      • Vienna, Austria, 1180
        • General Hospital of Vienna
  • Belgium
      • Leuven, Belgium
        • Uz Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Halifax Infirmary
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G4
        • Victoria Medical Centre
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital
    • Quebec
      • Sainte Foy, Quebec, Canada, G1V 4G5
        • Centre de Pneumologie de L'Hospital Laval
  • China
      • Hong Kong, China
        • Queen Mary Hospital
  • Czech Republic
      • Prague, Czech Republic
        • Interni klinika VFN
  • France
      • Marseille, France, 13005
        • Marseille-Timone
  • Germany
      • Greifswald, Germany, 17487
        • Universitat Greifswald
      • Greifswald, Germany
        • Universitat Greifswald
      • Hamburg, Germany
        • Universitärsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany
        • Medizinische Universitätsklinik
      • Leipzig, Germany
        • Universitatsklinikim Leipzig
      • Regensburg, Germany
        • Klinikum der Universität Regensburg
  • Italy
      • Bologna, Italy
        • Policlinico S. Orsola-Malpighi
  • Netherlands
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Maastricht, Netherlands
        • University Hospital Maastricht
  • Spain
      • Barcelona, Spain
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital Valle d'Hebron
      • Madrid, Spain
        • Hospital 12 de Octubre
  • Switzerland
      • Zurich, Switzerland
        • Zurich University Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB3 8RE
        • Papworth Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama-Birmingham
    • California
      • Torrance, California, United States, 90509
        • Harbor Ucla Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts- New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Texas
      • Dallas, Texas, United States, 75390
        • St. Paul University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: bosentan
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
Other Names:
  • Tracleer
Placebo Comparator: 2
placebo for 6 months followed by an open label period
Drug: placebo
placebo for 6 months followed by an open-label period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
exercise capacity
Time Frame: Baseline to end of study
Baseline to end of study
cardiac hemodynamics
Time Frame: Baseline to end of study
Baseline to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 16, 2004

First Submitted That Met QC Criteria

September 17, 2004

First Posted (Estimate)

September 20, 2004

Study Record Updates

Last Update Posted (Estimate)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EARLY
  • AC-052-364

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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