CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 207 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Suvorexant 15 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/NCT04571944
NCT04571944Phase 3Completed
CompareCT.gov

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of MK-4305 (Suvorexant) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium

Merck Sharp & Dohme LLC·interventional·Posted Oct 1, 2020·Updated Nov 25, 2024

In Brief

A Phase 3 clinical trial evaluating Suvorexant and Placebo for Delirium. Completed, enrolled 207 participants across 50 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 1, 2020
Enrollment StartOct 22, 2020
Primary CompletionDec 23, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.8 years ago

Interventions

Suvorexantdrug

Suvorexant administered at a dose of 15 mg QD via oral tablet

Placebodrug

Suvorexant-matching placebo administered QD via oral tablet