The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) 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
428
oral administration (capsules)
oral administration (capsules)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Time frame: 56 days
Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.
Time frame: 56 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.