MedTrace Logo

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

NCT06680505 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-11-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-04
Primary Completion
2020-09-30
Completion
2021-03-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680505 on ClinicalTrials.gov