Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03439514
Status:
TERMINATED
Last Update Posted:
2024-01-09
First Post:
2018-02-01
Brief Title:
A Study of ARRY-371797 PF-07265803 in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin AC Gene Mutation
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Multinational Randomized Placebo-controlled Study of ARRY-371797 PF-07265803 in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin AC Gene Mutation REALM-DCM
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor terminated the study due to futility The decision to stop the study was not based on safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REALM-DCM
Brief Summary:
This is a randomized double-blind placebo-controlled study in patients with dilated cardiomyopathy DCM due to a mutation of the gene encoding the lamin AC protein LMNA The study will further evaluate a dose level of study drug ARRY-371797 that has shown preliminary efficacy and safety in this patient population After the primary analysis has been performed eligible patients may receive open-label treatment with ARRY-371797
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 |
|---|---|---|---|
| 2017-004310-25 | EUDRACT_NUMBER | Alias Study Number | None |
| C4411002 | OTHER | None | None |