Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432614
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2007-02-07
Brief Title:
Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multi-National Multi-Center DB Placebo-Controlled Parallel Group Fixed Dose Efficacy Safety Study of SR58611A 350 mg Twice Daily vs Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mgd
Status:
COMPLETED
Status Verified Date:
2009-03
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:
ALBERIO
Brief Summary:
The primary objective of the study is to compare after 8 weeks the efficacy of SR58611A vs placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2006-004146-16 | None | None | None |