Clinical trial
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER)…
NCT00490971 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed
Key facts
| NCT number | NCT00490971 |
|---|---|
| Title | A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder |
| Official title | A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder |
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Olanzapine, Paliperidone ER, Placebo |
| Enrollment | 768 |
| Start date | May 1, 2006 |
| Primary completion | Apr 1, 2010 |
| Completion | Apr 1, 2010 |
| First posted | Jun 25, 2007 |
| Last update posted | Apr 15, 2015 |
| Countries | Bulgaria, China, Costa Rica, France, Germany, India, Malaysia, Panama, Poland, Romania, Russia, Serbia and 4 more |
At a glance
- 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: