At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 128 enrolled
Drug / intervention
Bosentandrug
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.
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
In Brief
A Phase 3 clinical trial evaluating Bosentan for Idiopathic Pulmonary Fibrosis. Completed, enrolled 128 participants.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartApr 2008
Primary CompletionApr 2010
Study CompletionMay 2010
TodayJul 2026
First PostedMar 7, 2008
Enrollment StartApr 1, 2008
Primary CompletionApr 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.3 years ago
Interventions
Bosentandrug
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.)