Ignite Creation Date:
2024-05-05 @ 9:30 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00903331
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2009-05-14
Brief Title:
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Multicenter Parallel Group Study to Evaluate the Efficacy Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2014-01
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:
MUSIC
Brief Summary:
The AC-055B201MUSIC study is a Phase II study comparing one dose of ACT-064922 macitentan 10 mg with placebo in patients with idiopathic pulmonary fibrosis IPF The main study objective is to demonstrate that macitentan positively affects the forced vital capacity FVC in comparison with placebo in patients with idiopathic pulmonary fibrosis IPF
The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF and to evaluate the benefitrisk profile of macitentan in the treatment of patients with IPF
The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF and to evaluate the benefitrisk profile of macitentan in the treatment of patients with IPF
Detailed Description:
The study included two treatment periods Period 1 fixed duration from randomization up to the primary endpoint evaluation Month 12 or earlier in case of premature discontinuation of study drug and Period 2 variable duration from the primary endpoint evaluation visit up to the end of study EOS EOS occurred when the last patient randomized and not prematurely discontinued completed Period 1
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