CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
MK-7288 +3 moredrug
Likely dose
MK-7288 10 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/NCT01092780
NCT01092780Phase 1Completed

An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients

Merck Sharp & Dohme LLC·interventional·Posted Mar 25, 2010·Updated Nov 8, 2018

In Brief

A Phase 1 clinical trial evaluating MK-7288, Placebo to MK-7288, and 2 other interventions for Apnea, Sleep. Completed, enrolled 56 participants.

Detailed Summary

This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsApnea, Sleep
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2010
Enrollment StartMay 26, 2010
Primary CompletionMay 31, 2011
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 16.3 years ago

Interventions

MK-7288drug

one or two 10 mg capsules, orally, single dose

Placebo to MK-7288drug

one or two capsules, orally, single dose

Modafinildrug

two 100 mg tablets, orally, single dose

Placebo to modafinildrug

two 100 mg tablets, orally, single dose