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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
365
oral administration (capsules)
oral administration (capsules)
oral administration (capsules)
Sanofi-Aventis Administrative Office
Brussels, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Time frame: Baseline, Day 56
Change from baseline in the Clinical Global Impression Severity of Illness score.
Time frame: Baseline, Day 56
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Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Stockholm, Sweden
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)