Conditions: Hypertriglyceridemia
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 503
Healthy volunteers: no

Brief summary:
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.

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, 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.

Arms:
arm 1: TAK-085 2 g, orally, once daily for up to 52 weeks. arm 2: TAK-085 2 g, orally, twice daily for up to 52 weeks. arm 3: Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.

Interventions: intervention 1: omega-3-acid ethyl esters 90 (TAK-085) intervention 2: Eicosapentaenoic acid-ethyl (EPA)
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 capsules

Protocol document: