Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391443
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2006-10-20
Brief Title:
BUILD 3 Bosentan Use in Interstitial Lung Disease
Sponsor:
Actelion
Organization:
Actelion
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUILD 3
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None