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
366
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Laval, Canada
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 key secondary efficacy outcome is change from baseline in the Clinical Global Impression Severity of Illness score.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.