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


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Sponsored by:	Actelion
Information provided by:	Actelion

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	Treatment or Intervention	Phase
Pulmonary Hypertension	Drug: bosentan	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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)

Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both

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)

Australia
The Prince Charles Hospital, Brisbane, 4032, Australia; Recruiting

Keith McNeil, MD +61(0)7335081111 keith_mcneil@health.gld.gov.au

The Alfred Hospital, Melbourne, 3004, Australia; Recruiting

Trevor Williams, MD +61(0)395292489 t.williams@alfred.org.au

Austria
General Hospital of Vienna, Vienna, 1180, Austria; Recruiting

Irene Lang, MD +43(0)1404004605 irene.lang@univie.ac.at

France
Marseille-Timone, Marseille, 13005, France; Recruiting

Gerald Simonneau, MD +33(0)145374779 gerald.simonneau@abc.ap-hop-paris.fr

Germany
Medizinische Hochschule Hannover, Hannover, 30625, Germany; Recruiting

Marius Hoeper, MD +49(0)5115323934 hoeper.maruis@mh-hannover.de

Universitat Greifswald, Greifswald, 17487, Germany; Not yet recruiting

Ralf Ewert, MD +49(0)3834866776 ewert@uni-greifswald.de

United Kingdom
Papworth Hospital, Cambridge, CB3 8RE, United Kingdom; Not yet recruiting

Joanna Pepke-Zaba, MD +44(0)1480830541 joanna.pepkezaba@papworth.nhs.uk

Study ID Numbers: EARLY; AC-052-364
Record last reviewed: September 2004
Record first received: September 16, 2004
ClinicalTrials.gov Identifier: NCT00091715
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-19