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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With An Open-Label Extension Evaluating Extended Release OROS Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With An Open-Label Extension Evaluating Extended Release OROS Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2016

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At a glance

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

    • 18 Jul 2016 Result of post-hoc analysis of this and one other phase III trial published in the International Clinical Psychopharmacology (2016).
    • 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.
    • 12 Dec 2007 The open-label extension phase of this trial has been completed, according to the media release of Janssen L.P. The open-label trial included 235 patients.
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