A North-American Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT00390650|
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : April 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Drug: Saredutant||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Patients With Generalized Anxiety Disorder|
|Study Start Date :||October 2006|
|Primary Completion Date :||November 2007|
|Study Completion Date :||November 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390650
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Marie TRAD, MD||Sanofi|