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

NCT00855530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2009-03-25

No results posted yet for this study

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

DRUG

amibegron (SR58611A)

oral administration of 300 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Argentina
  • Chile
  • Greece
  • Hong Kong
  • Morocco
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Taiwan
  • Tunisia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855530 on ClinicalTrials.gov