Status:
COMPLETED
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
Eligibility Criteria
Inclusion
- Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
- Must be willing to stay overnight at a sleep laboratory
- Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
- Regular bedtime is between 9 PM and 12 AM (midnight)
Exclusion
- Breast feeding, pregnant or planning to become pregnant during the study
- Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
- Currently participating or have participated in a study with an investigational compound or device within the last 30 days
- Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
- Has done shift work within the past 2 weeks
- Has donated blood products within the last 8 weeks
- Has difficulty sleeping due to a medical condition
Key Trial Info
Start Date :
November 5 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2009
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00792298
Start Date
November 5 2008
End Date
December 26 2009
Last Update
November 6 2018
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