Status:
COMPLETED
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
35-64 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
- Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
- Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
- Subjects must use continuous positive airway pressure (CPAP).
- Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).
Exclusion
- Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
- Subject has a history of, or current malignancy except for non melanomatous skin cancer.
- Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
- Subject is known to be seropositive for human immunodeficiency virus (HIV).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00685269
Start Date
August 1 2003
End Date
January 1 2004
Last Update
February 22 2012
Active Locations (2)
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1
Atlanta, Georgia, United States
2
Cincinnati, Ohio, United States