NCT01300455

Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)

A Study to Evaluate the Effects of MK-4305 in Patients With Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is that multiple doses of MK-4305 do not produce a clinically significant increase in Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DRUG	Suvorexant	40 mg tablets, orally once daily for 4 consecutive days in the evening
DRUG	Matching Placebo	Placebo tablets, orally once daily for 4 consecutive days in the evening

Timeline

• Start date: 2011-03-19
• Primary completion: 2011-08-11
• Completion: 2011-08-11
• First posted: 2011-02-21
• Last updated: 2018-09-21
• Results posted: 2014-08-29