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NCT00490971 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 768
- Enrollment target
NCT00490971 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 768 participants.
The verdict
NCT00490971, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 768 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.
Interventions
- DRUG Placebo
- DRUG Olanzapine
- DRUG Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 768 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00490971
The ClinicalTrials.gov registry entry for NCT00490971 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 768 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00490971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00490971 about?
NCT00490971 is a clinical study titled "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". The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with p...
What is the current status of trial NCT00490971?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 768 participants. The study started on 2006-05. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00490971?
The interventions under investigation include: Placebo (DRUG), Olanzapine (DRUG), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00490971?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
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