Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II - Full Text View

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00091715

Purpose

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.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: bosentan Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Bosentan

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

exercise capacity [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
cardiac hemodynamics [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Enrollment:	185
Study Start Date:	April 2004
Estimated Study Completion Date:	January 2011
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator placebo for 6 months followed by an open label period	Drug: placebo placebo for 6 months followed by an open-label period

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091715

Hide Study Locations

Locations

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

Sponsors and Collaborators

Actelion

More Information

No publications provided by Actelion

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Galiè 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.

Responsible Party:	Actelion ( Sponsor )
Study ID Numbers:	EARLY, AC-052-364
Study First Received:	September 16, 2004
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00091715 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

Pulmonary arterial hypertension
PAH
PPH
bosentan
early

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Bosentan
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009