Efficacy of TAK-085 in Participants With Hypertriglyceridemia

Takeda

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Omega-3-acid ethyl esters 90 (TAK-085); Drug: Eicosapentaenoic acid-ethyl (EPA-E)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01350973

JapicCTI-R140452 (Registry Identifier)

TAK-085/CCT-002

U1111-1120-7801 (Registry Identifier)

JapicCTI-090937 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 611 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
2. Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Exclusion criteria

1. Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
3. Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
4. Participants who have been diagnosed with pancreatitis.
5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
6. Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

611 participants in 3 patient groups

TAK-085 2 g

Experimental group

Description:

TAK-085 2 g, orally, once daily for up to 12 weeks.

Treatment:

Drug: Omega-3-acid ethyl esters 90 (TAK-085)

TAK-085 4 g

Experimental group

Description:

TAK-085 2 g, orally, twice daily for up to 12 weeks.

Treatment:

Drug: Omega-3-acid ethyl esters 90 (TAK-085)

EPA-E 1.8 g

Experimental group

Description:

Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.

Treatment:

Drug: Eicosapentaenoic acid-ethyl (EPA-E)