NCT05970510

A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg	orally once a day
DRUG	Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg	orally once a day
DRUG	placebo	orally once a day

Timeline

• Start date: 2023-07-12
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-08-01
• Last updated: 2024-03-15

Locations

1 site across 1 country: China