drugset / Trial / NCT01438060
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Phase 3
Completed
232 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.
Timeline
- Start
- 2000-08
- Primary completion
- 2010-07
- Completion
- 2010-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Aripiprazole; p = 0.169; Mean Difference (Final Values) -1.02 (95% CI -2.49 to 0.44); ANCOVA NCT01438060 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | — | Oral |