Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352144
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2006-07-12
Brief Title:
6-Month Chronic Efficacy Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Six-Month Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia A Randomized Double-Blind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2012-02
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:
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures compared to placebo
Detailed Description:
This is a double blind randomized 21 eszopiclone placebo placebo-controlled multicenter study of eszopiclone in subjects with primary insomnia The study will involve up to 9 visits and subject participation will be approximately 224 days After meeting all screening criteria subjects will be randomized to either eszopiclone 3 mg QD or placebo This study was previously posted by Sepracor Inc In October 2009 Sepracor Inc was acquired by Dainippon Sumitomo Pharma and in October 2010 Sepracor Incs name was changed to Sunovion Pharmaceuticals Inc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None