Trials / Recruiting
RecruitingNCT05525637
Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,041 (estimated)
- 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 assess efficacy and safety of YZJ-1139 in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YZJ-1139 20mg | YZJ-1139 20mg tablets, once daily in the evening |
| DRUG | YZJ-1139 40mg | YZJ-1139 40mg tablets, once daily in the evening |
| DRUG | Placebo | Match placebo tablets, once daily in the evening |
Timeline
- Start date
- 2021-12-17
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2022-09-01
- Last updated
- 2024-04-18
Locations
88 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05525637. Inclusion in this directory is not an endorsement.