Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood

NCT ID: NCT02839902

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-27
• Study Completion Date: 2017-08-30

Brief Summary

The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl esters.

Detailed Description

This study was designed to explore the effects of omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor in comparison with the control group of patients not treated with omega-3-acid ethyl esters in an unblinded manner by use of high performance liquid chromatography (HPLC) using highly-sensitive gel filtration columns, which is a technique for analyzing lipoprotein.

Study participants who gave consent and were assessed as eligible in the eligibility assessment will be stratified by the factors of "fasting triacylglycerol (TG; <300 mg/dL or 300 mg/dL≤) and age (<65 years or 65 years≤) at the start of the screening period" and allocated to either the group treated with omega-3-acid ethyl esters or the group not treated with omega-3-acid ethyl esters (1:1 ratio).

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TAK-085 4g

A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule is orally administered immediately after meal twice a daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.

Group Type: EXPERIMENTAL

TAK-085

Intervention Type: DRUG

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

Control Group

Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.

Group Type: EXPERIMENTAL

Not treated with omega-3-acid ethyl esters

Intervention Type: OTHER

Not treated with omega-3-acid ethyl esters

Interventions

TAK-085

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

Intervention Type: DRUG

Not treated with omega-3-acid ethyl esters

Not treated with omega-3-acid ethyl esters

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participants diagnosed as hyperlipidemia.

2. Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the start of the observation period.

3. Participants with fasting TG of 150≤ to <400 mg/dL measured at the start of the observation period at Visit 1 (Week -4).

4. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.

5. Participants who can provide written informed consent prior to the conduction of the clinical study procedures.

6. Participants aged ≥20 years at the time of informed consent at Visit 1 (Week -4).

Exclusion Criteria

1. Participants who had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to the start of the observation period, or those who concurrently have the above disorders.

2. Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to the start of the observation period, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder.

3. Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to the start of observation period.

4. Participants who received an eicosapentaenoic acid (EPA) preparation or an EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks prior to the start of observation period.

5. Participants who started antidyslipidemic agents within 4 weeks prior to the start of observation period.

6. Participants with severe hepatic impairment (e.g., Child-Pugh classification C).

7. Participants who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency.

8. Participants who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia.

9. Diabetic participants who are currently receiving thiazolidine or insulin.

10. Participants who are concurrently having hypertension of grade IIINote 1). Note 1: Participants with systolic blood pressure of ≥180 mm Hg or diastolic blood pressure of ≥110 mm Hg regardless of treatment with antihypertensive drugs.

11. Participants who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol), or participants with or with a history of drug abuse or addiction.

12. Pregnant, lactating or postmenopausal women.

13. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters.

14. Participants participating in other clinical studies.

15. Participants assessed ineligible in the study by the principal investigator or the investigator.

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

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Noda, Chiba, Japan

Koga, Ibaragi, Japan

Moriguchi, Osaka, Japan

Suita, Osaka, Japan

Fujimi, Saitama, Japan

Mitaka, Tokyo, Japan

Saitama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1185-0054

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-163322

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-085-4002

Identifier Type: -

Identifier Source: org_study_id