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A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia.

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Trial Profile

A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2022

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Schizophrenia
  • Focus Adverse reactions; Registrational
  • Acronyms ZENITH
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 01 Mar 2022 Results evaluating the short- and long-term effects of brexpiprazole on patient functioning in schizophrenia using post hoc analysis of short and long term studies published in the Journal of Clinical Psychiatry
  • 23 Oct 2019 Results of post hoc analysis of data from two 6-week, randomized, double-blind, placebo-controlled studies (ClinicalTrials.gov identifiers, NCT01396421 and NCT01393613) and a 52-week, open-label, extension study (NCT01397786) assessing the short and long term efficacy of brexpiprazole for reducing agitation and hostility in schizophrenia published in the Journal of Clinical Psychopharmacology
  • 01 Jan 2019 Argentina, Bulgaria, Chile, India,Lithuania, Slovakia, South Africa, Turkey were the planned locations as per European Clinical Trials Database.

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