Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

• Status: Completed
• Trial end date: 2009-12-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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