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NCT00488319 · ClinicalTrials.gov registry record · Phase 3

Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

A Phase 3 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
400
Enrollment target

NCT00488319 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 400 participants.

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The verdict

NCT00488319, a Phase 3 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
400 participants
Enrollment target

Study Summary

The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.

Interventions

  • DRUG Paliperidone ER

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2007-06
Est. Completion 2012-07
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT00488319

The ClinicalTrials.gov registry entry for NCT00488319 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Paliperidone ER is the first listed.

NCT00488319 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00488319 about?

NCT00488319 is a clinical study titled "Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.". The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.

What is the current status of trial NCT00488319?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2007-06. Estimated completion is 2012-07.

What interventions are being tested in trial NCT00488319?

The interventions under investigation include: Paliperidone ER (DRUG).

Who is sponsoring clinical trial NCT00488319?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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

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.