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

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: September 16, 2004
Last updated: August 26, 2011
Last verified: August 2011
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
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)

Resource links provided by NLM:

Further study details as provided by Actelion:

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

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


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00091715

  Show 34 Study Locations
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Actelion Identifier: NCT00091715     History of Changes
Other Study ID Numbers: EARLY
Study First Received: September 16, 2004
Last Updated: August 26, 2011

Keywords provided by Actelion:
Pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017