Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01346930
Status:
WITHDRAWN
Last Update Posted:
2014-09-03
First Post:
2011-05-02
Brief Title:
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Long Term Single-arm Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Status:
WITHDRAWN
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to Protocol AC-055B201 MUSIC not meeting its primary end point
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSIC OL
Brief Summary:
The MUSIC OL study is an open-label extension study in which all eligible patients having completed the double-blind AC-055B201MUSIC study as scheduled receive macitentan 10 mg once daily The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis IPF
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