Status:
COMPLETED
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)
Lead Sponsor:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depre...
Eligibility Criteria
Inclusion
- Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.
Exclusion
- Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00831415
Start Date
March 1 2009
End Date
March 1 2011
Last Update
December 7 2018
Active Locations (17)
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1
Pfizer Investigational Site
Aichi, Japan
2
Pfizer Investigational Site
Chiba, Japan
3
Pfizer Investigational Site
Fukuoka, Japan
4
Pfizer Investigational Site
Fukushima, Japan