Status:
TERMINATED
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Sleep Apnea, Obstructive
Hypopnea Syndrome
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS...
Eligibility Criteria
Inclusion
- Patient is male or female and is at least 18 years old and less than 65 years old
- Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
- Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
- Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments
- Patient is willing to refrain from napping for the duration of the study
Exclusion
- Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months
- Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
- Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1
- Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00620659
Start Date
February 1 2008
End Date
February 1 2009
Last Update
May 13 2015
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