CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Suvorexant 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01300455
NCT01300455Phase 1Completed
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A Study to Evaluate the Effects of MK-4305 in Patients With Obstructive Sleep Apnea

Merck Sharp & Dohme LLC·interventional·Posted Feb 21, 2011·Updated Sep 21, 2018

In Brief

A Phase 1 clinical trial evaluating Suvorexant and Matching Placebo for Sleep Apnea. Completed, enrolled 26 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2011
Enrollment StartMar 19, 2011
Primary CompletionAug 11, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.4 years ago

Interventions

Suvorexantdrug

40 mg tablets, orally once daily for 4 consecutive days in the evening

Matching Placebodrug

Placebo tablets, orally once daily for 4 consecutive days in the evening