Conditions: Hypertriglyceridemia
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 611
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine the efficacy and safety 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.

Detailed description:
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, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Arms:
arm 1: TAK-085 2 g, orally, once daily for up to 12 weeks. arm 2: TAK-085 2 g, orally, twice daily for up to 12 weeks. arm 3: Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.

Interventions: intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) intervention 2: Eicosapentaenoic acid-ethyl (EPA-E)
Intervention descriptions: intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters. intervention 2: EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Protocol document: