At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 294 enrolled

Drug / intervention

Paliperidonedrug

Likely dose

Paliperidone 12 milligramfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00566631

NCT00566631Phase 3Completed

Compare CT.gov

Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia

Janssen-Cilag International NV·interventional·Posted Dec 3, 2007·Updated Aug 2, 2013

In Brief

A Phase 3 clinical trial evaluating Paliperidone for Schizophrenia. Completed, enrolled 294 participants across 30 sites in 7 countries.

Detailed Summary

The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSchizophrenia

CountriesCroatia, France, Germany, Israel, Lithuania, Poland, Romania

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2007

First PostedDec 2007

Primary CompletionMay 2008

Study CompletionMay 2009

TodayJul 2026

First PostedDec 3, 2007

Enrollment StartJul 1, 2007

Primary CompletionMay 1, 2008

Study CompletionMay 1, 2009

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 18.6 years ago

Interventions

Paliperidonedrug

Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.