drugset / Trial / NCT01541371

A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia

NCT01541371

Phase 3 Completed 405 enrolled Xian-Janssen Pharmaceutical Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions \[a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder\] and hallucinations \[imagining things\], and withdrawal into the self) who were not satisfied with other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine, quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone ER tablets will also be assessed.

Timeline

Start
2008-07
Primary completion
2009-09
Completion
2009-09

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