Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232297
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 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 100 OR 300 mg for the Prevention of Ventricular Arrhythmia-Triggered ICD Interventions
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:
ICARIOS
Brief Summary:
Primary objective
to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions
Secondary objectives
to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population
to document SSR149744C plasma level during the study
to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions
Secondary objectives
to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population
to document SSR149744C plasma level during the study
Detailed Description:
None
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