Clinical trial
Aripiprazole in Children and Adolescents With Bipolar I Disorder
NCT00110461 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00110461 |
|---|---|
| Title | Aripiprazole in Children and Adolescents With Bipolar I Disorder |
| Official title | A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Aripiprazole, placebo |
| Enrollment | 296 |
| Start date | Mar 1, 2005 |
| Primary completion | Feb 1, 2007 |
| Completion | Feb 1, 2007 |
| First posted | May 10, 2005 |
| Last update posted | May 21, 2012 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: