A phase III, randomized, placebo-controlled, double-blind trial evaluating the safety and efficacy of sublingual asenapine vs. olanzapine and placebo in in-patients with an acute manic episode

Trial Profile

A phase III, randomized, placebo-controlled, double-blind trial evaluating the safety and efficacy of sublingual asenapine vs. olanzapine and placebo in in-patients with an acute manic episode

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2017

At a glance

  • Drugs Asenapine (Primary) ; Olanzapine
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms ARES
  • Sponsors Merck Sharp & Dohme; Organon; Pfizer
  • Most Recent Events

    • 15 Feb 2013 A post hoc analysis of pooled data from 2 phase 3 studies and their extension study, was published in Journal of Affective Disorder.
    • 03 Sep 2010 Asenapine has been approved in the EU for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults based on the results of the ARES trials, and a trial of adjunctive asenapine, according to a Merck media release.
    • 06 Oct 2009 Schering-Plough added instead of Organon as Organon taken over by Schering-Plough.
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