NCT00855530

Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

A Fifty-Two-Week Multicenter, Open-Label, Study Evaluating the Long-Term Safety and Tolerability of SR58611A 350 mg q12 in Patients With Major Depressive Disorder.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: \- To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: \- To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.

Conditions

• Major Depressive Disorders

Interventions

Type	Name	Description
DRUG	amibegron (SR58611A)	oral administration of 300 mg twice daily

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2009-03-04
• Last updated: 2009-03-25

Locations

11 sites across 11 countries: Argentina, Chile, Greece, Hong Kong, Morocco, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia