Clinical trial
Aripiprazole Open-Label, Safety and Tolerability Study
NCT00102518 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00102518 |
|---|---|
| Title | Aripiprazole Open-Label, Safety and Tolerability Study |
| Official title | A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features |
| Acronym | APEX 241 |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Schizophrenia, Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Aripiprazole |
| Enrollment | 325 |
| Start date | Sep 1, 2004 |
| Primary completion | Feb 1, 2007 |
| Completion | Feb 1, 2007 |
| First posted | Jan 31, 2005 |
| Last update posted | Aug 31, 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: