A Double-Blind, Double-Dummy, Active-Controlled, Oral, Multiple-Dose, Two Stage Parallel, Randomized Inpatient Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients with Current Manic or Mixed Episode

Trial Profile

A Double-Blind, Double-Dummy, Active-Controlled, Oral, Multiple-Dose, Two Stage Parallel, Randomized Inpatient Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients with Current Manic or Mixed Episode

Completed
Phase of Trial: Phase II

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Endoxifen (Primary) ; Valproate semisodium
  • Indications Bipolar I disorders
  • Focus Therapeutic Use
  • Sponsors Intas Pharmaceuticals
  • Most Recent Events

    • 12 Mar 2016 Primary endpoint has been met, (Young Mania Rating Scale (YMRS) total score), according to the results published.
    • 12 Mar 2016 Results (n=84) presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 12 Mar 2016 Status changed from not yet recruiting to completed, according to the results published.
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