An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder
NCT00417118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365
Last updated 2016-05-24
Summary
The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.
Conditions
- Generalized Anxiety
Interventions
- DRUG
-
Saredutant
oral administration (capsules)
- DRUG
-
Escitalopram
oral administration (capsules)
- DRUG
-
oral administration (capsules)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2008-04-30
- Completion
- 2008-04-30
Countries
- Belgium
- Canada
- Finland
- France
- Italy
- Sweden
- Turkey (Türkiye)
Study Locations
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