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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00631475 |
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
Condition | Intervention | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis |
Drug: Bosentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 |
Estimated Enrollment: | 600 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
For patients who were administered bosentan during BUILD 3: Same dose will continue For patients who were administered placebo during BUILD 3: Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg |
Drug: Bosentan
For patients who were administered Bosentan during BUILD 3: continue on same dose For patients who were administered placebo during BUILD 3: Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients should have completed all the assessments from the BUILD 3 EOS visit.
Exclusion Criteria:
Study Chair: | Isabelle Leconte | Actelion |
Responsible Party: | Actelion ( Sebastien Roux, MD ) |
Study ID Numbers: | AC-052-322 |
Study First Received: | February 12, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00631475 |
Health Authority: | United States: Food and Drug Administration |
bosentan Tracleer Actelion |
BUILD 3 Idiopathic Pulmonary Fibrosis Interstitial Lung Disease |
Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis Hamman-Rich syndrome |
Lung Diseases Pulmonary Fibrosis Bosentan |
Pathologic Processes Therapeutic Uses Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |