Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT00770692
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Sponsor:
Eisai Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
Status:
COMPLETED
Status Verified Date:
2012-10
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 purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
Detailed Description:
This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: