drugset / Trial / NCT00385307

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)

NCT00385307

Phase 3 Completed 680 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Timeline

Start
2006-09
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject amibegron Small molecule 175 mg
Subject amibegron Small molecule 350 mg