Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03153111
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2017-03-30
Brief Title:
A Study to Evaluate Whether 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 Multi-center Double-blind Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Status:
COMPLETED
Status Verified Date:
2023-04
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:
SERENADE
Brief Summary:
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction HFpEF and pulmonary vascular disease
The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide NT-pro-BNP as compared to placebo in these patients
The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide NT-pro-BNP as compared to placebo in these patients
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 |
|---|---|---|---|
| 2016-003653-15 | EUDRACT_NUMBER | None | None |