A Phase 3 interventional study of Saredutant and Escitalopram in Generalized Anxiety, sponsored by Sanofi. Completed at 7 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 365 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
Saredutant 100 mg once daily in the morning for a maximum of 8 weeks
Drug: Saredutant
Escitalopram 10 mg once daily in the morning for a maximum of 8 weeks
Drug: Escitalopram
Placebo for one week during the run in period and for a maximum of 8 weeks during the active period
Drug: Placebo
oral administration (capsules)
oral administration (capsules)
oral administration (capsules)
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
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Sanofi