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NCT00535145 · ClinicalTrials.gov registry record · Phase 4
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
A Phase 4 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT00535145: Completed Phase 4 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
NCT00535145 is a Phase 4 study that has completed, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 121 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00535145, a Phase 4 study, has completed, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
Primary Outcome
Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.
Interventions
- DRUG Treatment as usual (TAU), Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
What the finished NCT00535145 record still lists
NCT00535145 is an interventional study that assigns participants to a tested intervention. The registered 121 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 (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment as usual (TAU), Paliperidone ER is the first listed.
NCT00535145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00535145 about?
NCT00535145 is a clinical study titled "Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease". The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
What is the current status of trial NCT00535145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2007-10. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00535145?
The interventions under investigation include: Treatment as usual (TAU), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00535145?
This trial is sponsored by Ortho-McNeil Janssen Scientific Affairs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00535145's enrollment target sits among peer trials
121 669th of 2000 higher than 1,328 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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