Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252343
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2005-11-10
Brief Title:
Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Eight-Week Double-Blind Placebo-Controlled Multicenter Study With Escitalopram 10mg qd as Positive Control Evaluating the Efficacy Safety Tolerability of a Fixed Dose of SR58611A 350 mg q12 in Outpatients With Generalized Anxiety Disorder
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:
LIBRA
Brief Summary:
To evaluate the efficacy of a fixed dose of SR58611A 350mg q12 compared to placebo in patients with GeneralizedAnxiety Disorder GAD using escitalopram 10 mg qd as positive control To evaluate the tolerability and safety of SR58611A in patients with GAD
Detailed Description:
The current study will be conducted to evaluate the efficacy safety and tolerability of SR58611A 350 mg q12 compared to placebo in patients with generalized anxiety disorder GAD using escitalopram 10 mg qd as a positive control This is an 8-week double-blind randomized 3-parallel-group placebo- and escitalopram-controlled studyA 1-week placebo single-blind period precedes the 8-week randomized treatment period A Safety Follow up Visit Segment C is scheduled 1 week after the acute treatmentperiod Segment B or early termination This trial is designed to compare the efficacy safety and tolerability of SR58611A to placebo In this study escitalopram a selective serotonin reuptake inhibitor SSRI antidepressant is used as a positive control and has been chosen as the comparator agentas it is approved for treatment of GAD at a dose of 10 mg once daily
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