Clinical trial
A Study to Evaluate the Efficacy and Safety of Adjustable Doses of…
NCT00309686 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed
Key facts
| NCT number | NCT00309686 |
|---|---|
| Title | A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder |
| Official title | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes 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 | Affective Psychosis, Bipolar, Bipolar Disorder, Mania |
| Intervention type | Drug |
| Interventions | Paliperidone ER |
| Enrollment | 300 |
| Start date | Apr 1, 2006 |
| Completion | Aug 1, 2007 |
| First posted | Apr 3, 2006 |
| Last update posted | May 18, 2011 |
At a glance
- No 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: