NCT00631475

Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443

Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Bosentan	For patients who were administered Bosentan during BUILD 3 (NCT00391443): continue on same dose For patients who were administered placebo during BUILD 3 (NCT00391443): Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs \< 90 lbs.)

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2008-03-07
• Last updated: 2025-02-04
• Results posted: 2012-08-03