A phase 3 randomized placebo-controlled double-blinded trial evaluating the safety and efficacy of asenapine in subjects continuing lithium or valproic acid/divalproex sodium for the treatment of an acute manic or mixed episode

Trial Profile

A phase 3 randomized placebo-controlled double-blinded trial evaluating the safety and efficacy of asenapine in subjects continuing lithium or valproic acid/divalproex sodium for the treatment of an acute manic or mixed episode

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2015

At a glance

  • Drugs Asenapine (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms APOLLO
  • Sponsors Merck & Co; Organon; Pfizer; Schering-Plough
  • Most Recent Events

    • 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 this trial and the monotherapy ARES trials, according to a Merck media release.
    • 22 May 2010 Results have been presented at the 163rd Annual Meeting of the American Psychiatric Association (APA).
    • 06 Oct 2009 Schering-Plough added as trial sponsor and affiliate as reported by ClinicalTrials.gov.
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