Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00855530
Collaborator
(none)
527
11
1
21.9
47.9
2.2
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
527 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date
:
Sep 1, 2005
Actual Primary Completion Date
:
Jul 1, 2007
Actual Study Completion Date
:
Jul 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: amibegron (SR58611A)
oral administration of 300 mg twice daily
|
Outcome Measures
Primary Outcome Measures
- Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists [54 weeks]
Secondary Outcome Measures
- 17-item Hamilton Depression rating Scale, Clinical Global Impression, Sheehan Disability Scale, Qol Enjoyment and satisfaction Questionnaire - Short Form,Medical Outcomes Study Short Form, Endicott Work Productivity Scale. [54 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of
18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Buenos Aires | Argentina | ||
| 2 | Sanofi-Aventis Administrative Office | Santiago | Chile | ||
| 3 | Sanofi-Aventis Administrative Office | Athens | Greece | ||
| 4 | Sanofi-Aventis Administrative Office | Causeway Bay | Hong Kong | ||
| 5 | Sanofi-Aventis Administrative Office | Casablanca | Morocco | ||
| 6 | Sanofi-Aventis Administrative Office | Moscow | Russian Federation | ||
| 7 | Sanofi-Aventis Administrative Office | Singapore | Singapore | ||
| 8 | Sanofi-Aventis Administrative Office | Midrand | South Africa | ||
| 9 | Sanofi-Aventis Administrative Office | Barcelona | Spain | ||
| 10 | Sanofi-Aventis Administrative Office | Taipei | Taiwan | ||
| 11 | Sanofi-Aventis Administrative Office | Megrine | Tunisia |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: ICD CSD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00855530
Other Study ID Numbers:
- LTS4848
First Posted:
Mar 4, 2009
Last Update Posted:
Mar 25, 2009
Last Verified:
Mar 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: