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Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis

NCT00071461 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2012-02-24

No results posted yet for this study

Summary

Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis.

Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available.

The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF.

It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.

Conditions

Interventions

DRUG

bosentan

Initial dose: 62.5 mg b.i.d. for 4 weeks. * Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). * body weight \< 40 kg (90 lb): 62.5 mg b.i.d.

DRUG

Placebo

Initial dose: 62.5 mg b.i.d. for 4 weeks. * Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). * body weight \< 40 kg (90 lb): 62.5 mg b.i.d.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2005-09-30
Completion
2010-05-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00071461 on ClinicalTrials.gov