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

Sponsor:	Actelion
Information provided by (Responsible Party):	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 3

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

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
Study Completion Date:	February 2011
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Other Name: Tracleer
Placebo Comparator: 2 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

Show 34 Study Locations

Sponsors and Collaborators

Actelion

More Information

No publications provided by Actelion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
ClinicalTrials.gov Identifier:	NCT00091715 History of Changes
Other Study ID Numbers:	EARLY, AC-052-364
Study First Received:	September 16, 2004
Last Updated:	August 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

Pulmonary arterial hypertension
PAH
PPH
bosentan
early

Additional relevant MeSH terms:

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

Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012