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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 is a Phase 4 study that has completed, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 121 participants.

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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.

Interventions

  • DRUG Treatment as usual (TAU), Paliperidone ER

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2007-10
Est. Completion 2009-02
Phase Phase 4

What the Registry Record Tells You About NCT00535145

The ClinicalTrials.gov registry entry for NCT00535145 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ortho-McNeil Janssen Scientific Affairs, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Treatment as usual (TAU), Paliperidone ER is the first listed.

NCT00535145 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.