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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Jul 2019

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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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