CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 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/NCT01293006
NCT01293006Phase 1Completed
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A Study to Evaluate the Effects of MK-4305 in Patients With Chronic Obstructive Pulmonary Disease

Merck Sharp & Dohme LLC·interventional·Posted Feb 10, 2011·Updated Sep 21, 2018

In Brief

A Phase 1 clinical trial evaluating suvorexant and Placebo for Insomnia. Completed, enrolled 25 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 chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2011
Enrollment StartMar 25, 2011
Primary CompletionJan 20, 2012
Study CompletionFeb 22, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.4 years ago

Interventions

suvorexantdrug

one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants \<65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days

Placebodrug

one tablet matching suvorexant, orally, once daily, for 4 consecutive days