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

Takeda53 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hyperlipidemia

Interventions

TAK-085DRUG

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

Not treated with omega-3-acid ethyl estersOTHER

Not treated with omega-3-acid ethyl esters

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Noda, Chiba, Japan

Unnamed facility

Koga, Ibaragi, Japan

Unnamed facility

Moriguchi, Osaka, Japan

Unnamed facility

Suita, Osaka, Japan

Unnamed facility

Outcomes

Primary Outcomes

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction

Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8.

Time frame: Baseline, Week 4 and Week 8

Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction

Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.

Time frame: Baseline, Week 4, and Week 8

Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents

Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures ("Change in mean particle sizes of sdLDL-C" and "Change in mean particle sizes of LDL-C") on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density.

Time frame: Baseline, Week 4, and Week 8

Secondary Outcomes

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction

Time frame: Baseline, Week 4 and Week 8

Data from ClinicalTrials.gov

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