BUILD 3: Bosentan Use in Interstitial Lung Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.|
- Time to Occurrence of Disease Worsening or Death up to End of Study. [ Time Frame: 36 months ] [ Designated as safety issue: No ]Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
- Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
|Study Start Date:||February 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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)
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)
Placebo Comparator: Placebo
Subjects receive placebo matching the bosentan treatment regimen
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391443
Show 117 Study Locations
|Study Director:||Isabelle Leconte||Actelion|