drugset / Trial / NCT00566631

An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia

NCT00566631

Phase 3 Completed 294 enrolled Janssen-Cilag International NV
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2007-07
Primary completion
2008-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Paliperidone Unknown 3 mg Oral
Subject Paliperidone Unknown 6 mg Oral
Subject Paliperidone Unknown 9 mg Oral
Subject Paliperidone Unknown 12 mg Oral

Indications