Hypertriglyceridemia Clinical Trial
Official title:
A Phase 3, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Long-term Administration of TAK-085 to the Patients With Hypertriglyceridemia.
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085
contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl
docosahexaenoic acid (DHA-E)).
This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of
TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the
safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle
modification.
The study period is a total of 56 weeks, comprised of a 4- week screening period and 52
weeks of treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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