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 350 mg and 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD). The 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
508
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Warsaw, Poland
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the CGI Severity of Illness Score, percentage of patients with HAM-A treatment response and change from baseline in the HAM-A somatic and psychic anxiety factor scores.
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Sanofi-Aventis Administrative Office
Belgrade, Serbia