Clinical trial
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
NCT00261443 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00261443 |
|---|---|
| Title | A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania |
| Official title | Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Lithium or Valproate with placebo (PBO), Lithium or Valproate with Aripiprazole |
| Enrollment | 1,270 |
| Start date | Sep 1, 2005 |
| Primary completion | Jun 1, 2009 |
| Completion | Oct 1, 2009 |
| First posted | Dec 5, 2005 |
| Last update posted | Apr 18, 2023 |
| Countries | Brazil, Bulgaria, Croatia, Czechia, France, India, Russia, South Africa, 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: