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| Sponsor: | Actelion |
|---|---|
| Information provided by: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00071461 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Pulmonary Fibrosis |
Drug: bosentan Drug: Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension |
| Enrollment: | 158 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | May 2010 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
Drug: bosentan
Initial dose: 62.5 mg b.i.d. for 4 weeks.
Other Name: Tracleer
|
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Placebo Comparator: 2
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
Drug: Placebo
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female patients over 18 years of age.
Exclusion Criteria:
Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements, e.g., the 6MWT or the PFTs.
(e.g., angina pectoris, intermittent claudicating, chronic arthritis).
Contacts and Locations
Show 29 Study Locations
More Information
| Responsible Party: | Sebastien Roux, MD, Actelion |
| ClinicalTrials.gov Identifier: | NCT00071461 History of Changes |
| Other Study ID Numbers: | AC-052-320, BUILD 1 |
| Study First Received: | October 23, 2003 |
| Last Updated: | April 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Idiopathic pulmonary fibrosis Interstitial lung disease Bosentan BUILD |
|
Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias |
Lung Diseases, Interstitial Bosentan Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |