NCT00417118

An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Generalized Anxiety

Interventions

Type	Name	Description
DRUG	Saredutant	oral administration (capsules)
DRUG	Escitalopram	oral administration (capsules)
DRUG	Placebo	oral administration (capsules)

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-12-29
• Last updated: 2016-05-24

Locations

7 sites across 7 countries: Belgium, Canada, Finland, France, Italy, Sweden, Turkey (Türkiye)