A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Male or female aged 18 to 65 years subjects;
• Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder;
• Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline;
• Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline;
• Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline.
Locations
Other Locations
China
Peking University Sixth Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhang Hongyan
hongyanzhang@bjmu.edu.cn
13601237138
Time Frame
Start Date: 2023-07-12
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 555
Treatments
Experimental: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group
orally once a day
Experimental: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group
orally once a day
Sham_comparator: Placebo
orally once a day
Related Therapeutic Areas
Sponsors
Leads: Luye Pharma Group Ltd.