NCT06680505

Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Primary Chronic Insomnia Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy and safety of YZJ-1139 in the short-term treatment of primary chronic insomnia, explore the optimal effective dose, and provide the basis for phase III clinical trials

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	YZJ-1139 10mg	YZJ-1139 10mg tablets
DRUG	YZJ-1139 20mg	YZJ-1139 20mg tablets
DRUG	YZJ-1139 40mg	YZJ-1139 40mg tablets
DRUG	YZJ-1139 60mg	YZJ-1139 60mg tablets
DRUG	Placebo	Match placebo tablets

Timeline

• Start date: 2019-08-04
• Primary completion: 2020-09-30
• Completion: 2021-03-29
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

33 sites across 1 country: China