drugset / Trial / NCT02168920

Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

NCT02168920

Phase 3 Terminated 150 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory \[CMAI\] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia

Timeline

Start
2014-06-11
Primary completion
2016-03-18
Completion
2016-03-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 2 mg
Subject Aripiprazole Other / unclassified 3 mg
Subject Aripiprazole Other / unclassified 6 mg

Indications

No indication recorded.