A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age.

Trial Profile

A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age.

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2014

At a glance

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

    • 15 Dec 2011 Results published in the Biological Psychiatry.
    • 11 Apr 2011 The US FDA has approved paliperidone for the treatment adolescents with schizophrenia, based on the results from this trial.
    • 08 Jun 2010 Actual patient numbers amended from 202 to 201 as reported by ClinicalTrials.gov.
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