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

Pulmonary Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091715
• Other study ID #: EARLY
• Secondary ID: AC-052-364
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2004
• Last updated: August 26, 2011
• Start date: April 2004
• Est. completion date: February 2011

Study information

• Verified date: August 2011
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: February 2011
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane
Australia	Royal Prince Albert Hospital	Camperdown
Australia	St. Vincent's Hospital	Darlinghurst
Austria	General Hospital of Vienna	Vienna
Belgium	UZ Gasthuisberg	Leuven
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Halifax Infirmary	Halifax	Nova Scotia
Canada	Victoria Medical Centre	Hamilton	Ontario
Canada	Centre de Pneumologie de L'Hospital Laval	Sainte Foy	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
China	Queen Mary Hospital	Hong Kong
Czech Republic	Interni klinika VFN	Prague
France	Marseille-Timone	Marseille
Germany	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
Italy	Policlinico S. Orsola-Malpighi	Bologna
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	University Hospital Maastricht	Maastricht
Spain	Hospital Clinic	Barcelona
Spain	Hospital Valle d'Hebron	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Switzerland	Zurich University Hospital	Zurich
United Kingdom	Papworth Hospital	Cambridge
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	Tufts- New England Medical Center	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	St. Paul University Hospital	Dallas	Texas
United States	Harbor UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity		Baseline to end of study	No
Primary	cardiac hemodynamics		Baseline to end of study	No