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OpenTrials
Completed

NCT Number: NCT00091715

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Prince Charles Hospital, Brisbane, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bosentan

Drug

65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study

Other names: Tracleer

Placebo

Drug

placebo for 6 months followed by an open-label period

Primary outcomes

  1. exercise capacity

    Time frame: Baseline to end of study

  2. cardiac hemodynamics

    Time frame: Baseline to end of study

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2011
First posted
Sep 20, 2004
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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