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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: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
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 |
What the finished NCT00590577 record still lists
NCT00590577 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00590577 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590577's enrollment target sits among peer trials
652 571st of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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