Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232310
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2005-10-03
Brief Title:
Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation fluttEr
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation Flutter
Status:
COMPLETED
Status Verified Date:
2012-05
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:
CORYFEE
Brief Summary:
Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillationflutter to sinus rhythm at the time of the planned electrical cardioversion
Detailed Description:
This is a dose ranging multicenter multinational randomized double blind placebo controlled parallel arm study Patients with AFAFL will be randomized to one of two doses of SSR149744C
The efficacy of SSR149744C will be based on the proportion of patients converting to normal sinus rhythm at the end of the treatment period 48 hours post first dose
Patients will receive the study drug on D1 and D2 Patients not converting pharmacologically to sinus rhythm will undergo an electrical cardioversion on D3
The efficacy of SSR149744C will be based on the proportion of patients converting to normal sinus rhythm at the end of the treatment period 48 hours post first dose
Patients will receive the study drug on D1 and D2 Patients not converting pharmacologically to sinus rhythm will undergo an electrical cardioversion on D3
Study Oversight
Has Oversight DMC:
None
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?:
None