CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 616 enrolled
Drug / intervention
Bosentan +1 moredrug
Likely dose
Bosentan 62.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00391443
NCT00391443Phase 3Completed
CompareCT.gov

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.

Actelion·interventional·Posted Oct 24, 2006·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating Bosentan and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 616 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2006
Enrollment StartFeb 1, 2007
Primary CompletionFeb 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.7 years ago

Interventions

Bosentandrug

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)

Placebodrug

Placebo matching bosentan 62.5 mg tablets and 125 mg tablets