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: 09 May 2018

At a glance

  • Drugs Cariprazine (Primary)
  • Indications Schizophrenia
  • Focus Adverse reactions; Registrational
  • Sponsors Forest Laboratories
  • Most Recent Events

    • 09 May 2018 Results of post-hoc analysis (n=112) assessing the efficacy of cariprazine on negative symptoms after up to 1 year of treatment using pooled data from 2 open-label, 48- week studies (NCT01104792, NCT00839852) along with supportive analysis results using data from the open-label run- in (8 week) and stabilization (12 week) phases of a long-term, cariprazine relapse-prevention study (NCT01412060), presented at the 171st Annual Meeting of the American Psychiatric Association.
    • 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.
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