drugset / Trial / NCT04571944

Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

NCT04571944

Phase 3 Completed 207 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindPrevention

Summary

The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for reducing the incidence of delirium in Japanese participants who are at high risk of delirium. The primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.

Timeline

Start
2020-10-22
Primary completion
2022-12-23
Completion
2022-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Suvorexant Small molecule 15 mg Oral

Indications