drugset / Trial / NCT00250614

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

NCT00250614

Phase 3 Completed 452 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression. The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.

Timeline

Start
2005-04
Primary completion
2006-10
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Saredutant Small molecule 100 mg

Indications