Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
Study NCT ID:
NCT06010693
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2023-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Investigate the Efficacy and Safety of 50 mg Daridorexant in Adult and Elderly Chinese Patients With Insomnia Disorder.
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant in adult and elderly chinese patients with insomnia disorder.
Efficacy will be evaluated on objective and subjective sleep parameters .
Efficacy will be evaluated on objective and subjective sleep parameters .
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: