Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia.
Phase of Trial: Phase III
Latest Information Update: 25 Jul 2017
At a glance
- Drugs Cariprazine (Primary)
- Indications Schizophrenia
- Focus Adverse reactions; Registrational
- Sponsors Forest Laboratories
- 16 Jun 2015 The US FDA notified Gideon Richter and Allergan of a three-month extension to complete its review of data supporting the cariprazine NDA, according to a media release. The NDA was submitted in late 2012. A complete response letter was issued by the FDA in November 2013, and the companies resubmitted information in December 2014.
- 20 Oct 2014 Results of a pooled analysis of extension trials NCT01104792 and NCT00839852 were presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.
- 16 Apr 2013 New source identified and integrated (Indian Clinical Trials Registry).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History