Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266747
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2005-12-16
Brief Title:
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Eight-WeekDble-BlindPlacebo-Controlled Multicenter Study With Paroxetine 20 mg q24 as Positive Control Evaluating the Efficacy Safety and 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:
AQUARIUS
Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder GADThe secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A
Detailed Description:
The study is a multicenter multicountry randomized parallel-group double blind placebo and paroxetine-controlled study consisting of three segments A B and C Segment A is a 1-week placebo single-blind period and Segment B is an 8-week double blind period All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication
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