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A Phase 3 Randomized, Placebo-and Active Comparator Controlled, CLinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

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Trial Profile

A Phase 3 Randomized, Placebo-and Active Comparator Controlled, CLinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Lurasidone (Primary) ; Olanzapine
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms PEARL-2
  • Sponsors Sumitomo Pharma America

    • Most Recent Events

    • 09 Nov 2021 Results of pooled analysis evaluating novelty of a safety profile of a drug in a new class (in clinical trials), against that of those already on the market (using pharmacovigilance data) published in the Clinical Drug Investigation
    • 15 Sep 2020 Results of post hoc analysis (n=246) evaluating proportion and characteristics of the patients who needed higher dose of lurasidone during 6-month open label extension study, presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
    • 15 Sep 2020 Results of a post hoc analysis assessing the long term effectiveness of lurasidone 40 to 80mg/d presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology

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