NCT00390533

An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder

An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Generalized Anxiety

Interventions

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

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-10-20
• Last updated: 2016-05-24

Locations

2 sites across 2 countries: United States, Australia