A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia.
Phase of Trial: Phase III
Latest Information Update: 07 Jul 2017
At a glance
- Drugs Cariprazine (Primary)
- Indications Schizophrenia
- Focus Registrational; Therapeutic Use
- Sponsors Forest Laboratories
- 20 Sep 2016 Post hoc pooled analysis results of this (NCT01104779) and other trials (NCT01058096, NCT00488618, NCT00404573, NCT01104766, NCT01058668, NCT00694707) presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
- 02 Aug 2016 According to Recordati media release, following the FDA approval in September 2015, the product was launched in the USA in March 2016 under the trademark of VRAYLAR for the treatment of both bipolar mania and schizophrenia. The European Medicines Agency (EMA) started the evaluation of Richter's marketing authorisation application for cariprazine for the treatment of schizophrenia in March 2016.
- 29 Mar 2016 According to a Gedeon Richter media release, the EMA has accepted the company's regulatory submission for cariprazine the treatment of schizophrenia in adult patients.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History