Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder
NCT00397098 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257
Last updated 2009-03-12
Summary
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A.
The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period.
The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.
Conditions
- Anxiety Disorders
Interventions
- DRUG
-
SR58611A
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ICD CSD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2007-09-30
- Completion
- 2007-09-30
Countries
- Australia
- Chile
- France
- Germany
- Hungary
- Italy
- Mexico
- Russia
- Spain
Study Locations
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