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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bosentan
placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary arterial hypertension, PAH, PPH, bosentan, early

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama-Birmingham
  • Harbor UCLA Medical Center
  • Tufts- New England Medical Center
  • University of Michigan
  • Cleveland Clinic Foundation
  • St. Paul University Hospital
  • The Prince Charles Hospital
  • Royal Prince Albert Hospital
  • St. Vincent's Hospital
  • General Hospital of Vienna
  • UZ Gasthuisberg
  • University of Calgary
  • University of Alberta
  • Halifax Infirmary
  • Victoria Medical Centre
  • Toronto General Hospital
  • Centre de Pneumologie de L'Hospital Laval
  • Queen Mary Hospital
  • Interni klinika VFN
  • Marseille-Timone
  • Universitat Greifswald
  • Universitat Greifswald
  • Universitarsklinikum Hamburg-Eppendorf
  • Medizinische Universitatsklinik
  • Universitatsklinikim Leipzig
  • Klinikum der Universitat Regensburg
  • Policlinico S. Orsola-Malpighi
  • VU Medisch Centrum
  • University Hospital Maastricht
  • Hospital Clinic
  • Hospital Valle d'Hebron
  • Hospital 12 de Octubre
  • Zurich University Hospital
  • Papworth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

placebo for 6 months followed by an open label period

Outcomes

Primary Outcome Measures

exercise capacity
cardiac hemodynamics

Secondary Outcome Measures

Full Information

First Posted
September 16, 2004
Last Updated
August 26, 2011
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00091715
Brief Title
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary arterial hypertension, PAH, PPH, bosentan, early

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo for 6 months followed by an open label period
Intervention Type
Drug
Intervention Name(s)
bosentan
Other Intervention Name(s)
Tracleer
Intervention Description
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo for 6 months followed by an open-label period
Primary Outcome Measure Information:
Title
exercise capacity
Time Frame
Baseline to end of study
Title
cardiac hemodynamics
Time Frame
Baseline to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Tufts- New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
St. Paul University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The Prince Charles Hospital
City
Brisbane
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Prince Albert Hospital
City
Camperdown
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
Country
Australia
Facility Name
General Hospital of Vienna
City
Vienna
ZIP/Postal Code
1180
Country
Austria
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Victoria Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G4
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Centre de Pneumologie de L'Hospital Laval
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Interni klinika VFN
City
Prague
Country
Czech Republic
Facility Name
Marseille-Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Universitat Greifswald
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
Universitat Greifswald
City
Greifswald
Country
Germany
Facility Name
Universitarsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Universitatsklinik
City
Heidelberg
Country
Germany
Facility Name
Universitatsklinikim Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum der Universitat Regensburg
City
Regensburg
Country
Germany
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
Country
Italy
Facility Name
VU Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
University Hospital Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital Valle d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Zurich University Hospital
City
Zurich
Country
Switzerland
Facility Name
Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB3 8RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18572079
Citation
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.
Results Reference
derived

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

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