Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233441
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2005-10-04
Brief Title:
Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50 100 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial FibrillationFlutter
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Placebo Controlled Double Blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50 100 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial FibrillationFlutter
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:
MAIA
Brief Summary:
Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical pharmacological or spontaneous conversion of AFAFL
Detailed Description:
This is a dose-ranging multicenter multinational randomized double-blind placebo-controlled parallel arm study with 4 SSR149744C dose regimens and amiodarone as a calibratorTo be eligible patients must be in normal sinus rhythm for at least one hour at randomization and must have an electrocardiogram documented history of recent AFAFL reverted to normal sinus rhythm by electrical pharmacological or spontaneous conversion
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