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NCT00590577 · ClinicalTrials.gov registry record · Phase 3
Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
NCT00590577 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 652 participants.
The verdict
NCT00590577, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks of treatment as compared with placebo in patients with schizophrenia.
Interventions
- DRUG Placebo
- DRUG Paliperidone palmitate 25 mg eq.
- DRUG Paliperidone palmitate 150 mg eq.
- DRUG Paliperidone palmitate 100 mg eq.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590577
The ClinicalTrials.gov registry entry for NCT00590577 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 652 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 4 interventions - of which Placebo is the first listed.
NCT00590577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00590577 about?
NCT00590577 is a clinical study titled "Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia". The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks of treatment as compare...
What is the current status of trial NCT00590577?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2007-03. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00590577?
The interventions under investigation include: Placebo (DRUG), Paliperidone palmitate 25 mg eq. (DRUG), Paliperidone palmitate 150 mg eq. (DRUG), Paliperidone palmitate 100 mg eq. (DRUG).
Who is sponsoring clinical trial NCT00590577?
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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