A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia.
Phase of Trial: Phase III
Latest Information Update: 14 Sep 2010
At a glance
- Drugs Paliperidone; Quetiapine
- Indications Schizophrenia
- Focus Registrational; Therapeutic Use
- Sponsors Janssen Research & Development
- 14 Sep 2010 US FDA approved NDA for paliperidone for the acute and maintenance treatment of schizophrenia based data from this and other pivotal trials.
- 09 Oct 2008 Study start date changed from May 2006 to April 2006, actual end date changed from July to September 2007 as reported by ClinicalTrials.gov.
- 13 Oct 2007 Primary endpoint achieved; results reported by Janssen L.P.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History