A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
NCT05970510 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555
Last updated 2024-03-15
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.
Conditions
- Generalized Anxiety Disorder
Interventions
- DRUG
-
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg
orally once a day
- DRUG
-
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
orally once a day
- DRUG
-
orally once a day
Sponsors & Collaborators
-
Luye Pharma Group Ltd.
lead INDUSTRY
Principal Investigators
-
Zhang Hongyan · Peking University Sixth Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-12
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
Countries
- China
Study Locations
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