Status:
COMPLETED
Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. T...
Eligibility Criteria
Inclusion
- Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.
Exclusion
- Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.
- Significant risk of suicide based on clinical judgment.
- Use of prohibited treatments
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01485887
Start Date
January 1 2012
End Date
January 1 2014
Last Update
January 28 2021
Active Locations (25)
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1
Nippon Medical School Chiba Hokusoh Hospital
Inzai, Chiba, Japan, 270-1694
2
Nakamoto Clinic
Noda, Chiba, Japan, 278-0033
3
Stress Care Yoshimura Clinic
Fukuoka, Fukuoka, Japan, 810-0041
4
Hatakeyama Clinic
Kitakyushu, Fukuoka, Japan, 802-0064