Clinical trial NCT00091715: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial hypertension
PAH
PPH
bosentan
early
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2004-09-20
Enrollment: 185
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: exercise capacity
timeFrame: Baseline to end of study
measure: cardiac hemodynamics
timeFrame: Baseline to end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Boston
country: United States
facility: Tufts- New England Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dallas
country: United States
facility: St. Paul University Hospital
state: Texas
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
city: Camperdown
country: Australia
facility: Royal Prince Albert Hospital
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
city: Vienna
country: Austria
facility: General Hospital of Vienna
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: Hamilton
country: Canada
facility: Victoria Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Sainte Foy
country: Canada
facility: Centre de Pneumologie de L'Hospital Laval
state: Quebec
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Prague
country: Czech Republic
facility: Interni klinika VFN
city: Marseille
country: France
facility: Marseille-Timone
city: Greifswald
country: Germany
facility: Universitat Greifswald
city: Greifswald
country: Germany
facility: Universitat Greifswald
city: Hamburg
country: Germany
facility: Universitarsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Medizinische Universitatsklinik
city: Leipzig
country: Germany
facility: Universitatsklinikim Leipzig
city: Regensburg
country: Germany
facility: Klinikum der Universitat Regensburg
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Valle d'Hebron
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Zurich
country: Switzerland
facility: Zurich University Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
Study officials:
References:
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.