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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091715
Recruitment Status : Completed
First Posted : September 20, 2004
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: bosentan Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : April 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : February 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. exercise capacity [ Time Frame: Baseline to end of study ]
  2. cardiac hemodynamics [ Time Frame: Baseline to end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091715

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Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Actelion Identifier: NCT00091715    
Other Study ID Numbers: EARLY
First Posted: September 20, 2004    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011
Keywords provided by Actelion:
Pulmonary arterial hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action