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
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
- 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.