AN OPEN-LABEL, LONG-TERM EXTENSION, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VENLAFAXINE IN JAPANESE OUTPATIENTS WITH GENERALIZED ANXIETY DISORDER WHO COMPLETED STUDY B2411367
Phase 3
- Conditions
- GENERALIZED ANXIETY DISORDER
- Registration Number
- JPRN-jRCT2031220234
- Lead Sponsor
- IQVIA Services Japan K.K. jRCT Inquiry Contact
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Outpatient participants who have had no serious protocol deviation and completed 10 weeks of treatment including the tapering period, and who have had good tolerability to the study intervention, in the placebo-controlled double-blind comparative study of venlafaxine.
Exclusion Criteria
- Participants who demonstrate any clinically significant abnormalities in physical examination at baseline (Week 10 visit of the double-blind comparative study), or participants who have not recovered from clinically significant abnormalities in ECG assessment, clinical laboratory tests, or vital signs recorded prior to Week 10 visit in the preceding double-blind comparative study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method