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A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia.

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Trial Profile

A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2022

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At a glance

  • Drugs Aripiprazole (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ASPIRE-US
  • Sponsors Otsuka Pharmaceutical

Most Recent Events

  • 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.
  • 28 Feb 2013 Once-monthly aripiprazole extended-release (Abilify Maintena) was approved by the US FDA as a treatment for schizophrenia based on results from this trial according to an H. Lundbeck A/S media release.

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