Trials / Completed
CompletedNCT00391443
BUILD 3: Bosentan Use in Interstitial Lung Disease
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 616 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan | 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) |
| DRUG | Placebo | Placebo matching bosentan 62.5 mg tablets and 125 mg tablets |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2010-02-01
- Completion
- 2010-07-01
- First posted
- 2006-10-24
- Last updated
- 2025-02-04
- Results posted
- 2012-05-25
Source: ClinicalTrials.gov record NCT00391443. Inclusion in this directory is not an endorsement.