Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia: Phase 3

Trial Profile

Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia: Phase 3

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2017

At a glance

  • Drugs Lurasidone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms PASTEL
  • Sponsors Sumitomo Dainippon Pharma
  • Most Recent Events

    • 30 Jun 2015 Status changed from recruiting to completed as per ClinicalTrials.gov record.
    • 24 Apr 2015 Interim results published in the Media Release.
    • 24 Apr 2015 Sumitomo Dainippon Pharma announced in a media release that based on results of a pre-specified interim analysis, the company does not believe the trial results would warrant approval of production and distribution of lurasidone for the treatment of patients with schizophrenia in Japan, and is now reviewing its lurasidone development policy for Japan.
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