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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.

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Trial Profile

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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Sep 2010

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At a glance

  • Drugs Paliperidone (Primary) ; Quetiapine (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 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.

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