NCT04571944

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	Suvorexant	Suvorexant administered at a dose of 15 mg QD via oral tablet
DRUG	Placebo	Suvorexant-matching placebo administered QD via oral tablet

Timeline

• Start date: 2020-10-22
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2020-10-01
• Last updated: 2024-11-25
• Results posted: 2024-05-20

Locations

50 sites across 1 country: Japan