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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00091715
First received: September 16, 2004
Last updated: August 26, 2011
Last verified: August 2011
  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:


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
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 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):
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
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014