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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| B1 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| tolerability |
| Measure | Description | Time Frame |
|---|---|---|
| safety assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Santa Ana | California | United States | |||
| Local Institution |
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|
|
| Placebo | Drug | 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. |
|
| Hamden |
| Connecticut |
| United States |
| Local Institution | Hialeah | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | North Miami | Florida | United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Staten Island | New York | United States |
| Local Institution | Dayton | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Tulsa | Oklahoma | United States |
| Local Institution | Hershey | Pennsylvania | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Midvale | Utah | United States |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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