Trials / Completed
CompletedNCT03620981
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 410 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole | Drug: 1 tablet /day Once daily for 10 weeks |
| DRUG | Placebo | Placebo: 1 tablet /day Once daily for 10 weeks |
Timeline
- Start date
- 2018-08-20
- Primary completion
- 2023-04-21
- Completion
- 2023-05-15
- First posted
- 2018-08-08
- Last updated
- 2024-11-14
- Results posted
- 2024-11-14
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03620981. Inclusion in this directory is not an endorsement.