Ignite Creation Date:
2024-05-06 @ 12:16 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03714815
Status:
TERMINATED
Last Update Posted:
2023-09-22
First Post:
2018-10-19
Brief Title:
A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Long-term Multicenter Single-arm Open-label Extension of the SERENADE Study to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the absence of a positive trend in all efficacy parameters indicates that macitentan 10 mg does not have a beneficial effect in patients with HFpEF and PVD
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERENADE OL
Brief Summary:
The aim of this open-label OL extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction HFpEF and pulmonary vascular disease PVD beyond the treatment in the double-blind parent SERENADE study AC-055G202 NCT03153111 Furthermore this OL extension study will give eligible subjects of the main study SERENADEAC-055G202 NCT03153111 an opportunity to continue or start receiving macitentan
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001603-37 | EUDRACT_NUMBER | None | None |