Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia.

Trial Profile

Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia.

Completed
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
  • Most Recent Events

    • 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).
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