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NCT00524043 · ClinicalTrials.gov registry record · Phase 4
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
A Phase 4 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 4
- Development phase
- 201
- Enrollment target
NCT00524043: Completed Phase 4 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00524043 is a Phase 4 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 201 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00524043, a Phase 4 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 201 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.
Primary Outcome
The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.
Interventions
- DRUG Placebo
- DRUG Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
What the finished NCT00524043 record still lists
NCT00524043 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00524043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00524043 about?
NCT00524043 is a clinical study titled "An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia". The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.
What is the current status of trial NCT00524043?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 201 participants. The study started on 2007-09. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00524043?
The interventions under investigation include: Placebo (DRUG), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00524043?
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 NCT00524043's enrollment target sits among peer trials
201 406th of 2000 higher than 1,594 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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