Conditions: Idiopathic Pulmonary Fibrosis
Keywords: BUILD 3 Idiopathic Pulmonary Fibrosis Tracleer Interstitial Lung Disease bosentan Actelion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 616
Healthy volunteers: no

Brief summary:
BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

Detailed description:

Arms:
arm 1: Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg b.i.d. (if body weight \< 40 kg) arm 2: Subjects receive placebo matching the bosentan treatment regimen

Interventions: intervention 1: Bosentan intervention 2: Placebo
Intervention descriptions: intervention 1: Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight \< 40 kg) intervention 2: Placebo matching bosentan 62.5 mg tablets and 125 mg tablets

Protocol document: