Clinical trial
A Study to Evaluate the Efficacy and Safety of Flexible Doses of…
NCT00309699 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed
Key facts
| NCT number | NCT00309699 |
|---|---|
| Title | A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder |
| Official title | Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes in Bipolar Disorder |
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Bipolar Disorder, Mood Disorders |
| Intervention type | Drug |
| Interventions | Placebo, Quetiapine, Paliperidone ER |
| Enrollment | 493 |
| Start date | Apr 1, 2006 |
| Primary completion | Sep 1, 2007 |
| Completion | Nov 1, 2007 |
| First posted | Apr 3, 2006 |
| Last update posted | Jun 20, 2014 |
| Countries | Greece, Lithuania, Russia, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United States |
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.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: