Clinical trial
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With…
NCT00277212 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00277212 |
|---|---|
| Title | A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode |
| Official title | A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Collaborators | Otsuka America Pharmaceutical Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Lamotrigine + Aripiprazole, Lamotrigine + Placebo |
| Enrollment | 1,169 |
| Start date | Dec 1, 2005 |
| Primary completion | Jul 1, 2009 |
| Completion | Jul 1, 2009 |
| First posted | Jan 16, 2006 |
| Last update posted | Dec 2, 2013 |
| Countries | Puerto Rico, 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: