Trials / Completed
CompletedNCT00095719
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (planned)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 55 Years – 95 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to test the safety \& tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole | IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts. |
| DRUG | Placebo | IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts. |
Timeline
- Start date
- 2003-12-01
- Primary completion
- 2005-03-01
- Completion
- 2005-03-01
- First posted
- 2004-11-09
- Last updated
- 2013-11-11
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00095719. Inclusion in this directory is not an endorsement.