A Phase 3 interventional study of Saredutant in Anxiety, sponsored by Sanofi. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-06.
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 366 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.
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 study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi