Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-02 @ 12:01 PM
Study NCT ID:
NCT02064868
Status:
TERMINATED
Last Update Posted:
2019-03-22
First Post:
2014-02-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated based on results from pivotal adult AHF study CRLX030A2301
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELAX-AHF-EU
Brief Summary:
This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).
Detailed Description:
This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-002513-35 | EUDRACT_NUMBER | None | View |