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A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

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A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Oct 2021

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At a glance

  • Drugs Aripiprazole (Primary) ; Aripiprazole
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ASPIRE-EU
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 21 Oct 2014 Results of a post hoc analysis on the week 38 changes in the 5 Marder PANSS dimensions presented at 27th Annual Congress of European College of Neuropsychopharmacology.
    • 20 Oct 2014 Results of a post-hoc analysis of trials NCT00705783 and NCT00706654 were presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.
    • 12 Feb 2014 Results from this trial contributed to the approval of once-monthly intramuscular aripiprazole in Canada based on information reported in an Otsuka Pharmaceutical and H. Lundbeck A/S media release.

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