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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History