Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
Completed · Phase 2 · Has a placebo group
Conditions studied: Obstructive Sleep Apnea Syndrome
In brief
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
Key facts
- Study ID
- NCT00685269
- Run by
- Sumitomo Pharma America, Inc.
- People needed
- 20
- Starts
- 2003-08-01
- Expected to finish
- 2004-01-01
- Last updated by the study team
- 2012-02-22
Who can join
Age: 35 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- Study site — Atlanta, Georgia, United States
- Study site — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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