Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 7:14 AM
Study NCT ID:
NCT00685269
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome
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:
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
Detailed Description:
Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study Oversight
Has Oversight DMC:
False
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?: