A Study of Ramelteon in Chinese Patients With Chronic Insomnia
NCT06512363 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2024-07-22
Summary
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.
Efficacy will be evaluated on objective and subjective sleep parameters.
Conditions
- Chronic Insomnia
Interventions
- DRUG
-
Ramelteon
Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
- DRUG
-
Ramelteon placebo
Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.
Sponsors & Collaborators
-
Nanjing Chia-tai Tianqing Pharmaceutical
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-31
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
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