Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01739400
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2012-11-29
Brief Title:
Clinical Study to Assess the Long-term Safety Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Long Term Single-arm Open-label Extension Study of Protocol AC-055-305 to Assess the Safety Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary endpoint of parent study AC-055-305MAESTRO NCT01743001 not met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAESTRO-OL
Brief Summary:
Long-term study to evaluate if macitentan is safe tolerable and efficient enough to be used for treatment of Eisenmenger syndrome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None