Efficacy of TAK-085 in Participants With Hypertriglyceridemia

NCT ID: NCT01350973

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TAK-085 2 g

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

TAK-085 4 g

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

EPA-E 1.8 g

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

Group Type: EXPERIMENTAL

Eicosapentaenoic acid-ethyl (EPA-E)

Intervention Type: DRUG

EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Interventions

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

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 Type: DRUG

Eicosapentaenoic acid-ethyl (EPA-E)

EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Intervention Type: DRUG

Other Intervention Names

LOVAZA; Omacor; Atheropan®

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Associate Professor, Clinical Cell Biology and Medicine

Role: STUDY_DIRECTOR

Graduate School of Medicine, Chiba University

Other Identifiers

JapicCTI-090937

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1120-7801

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-R140452

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-085/CCT-002

Identifier Type: -

Identifier Source: org_study_id