Clinical trial NCT02839902: Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
Official title: Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction
timeFrame: Baseline, Week 4, and Week 8
measure: 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
timeFrame: Baseline, Week 4, and Week 8
Secondary outcomes:
measure: Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids
timeFrame: Baseline, Week 4 and Week 8
measure: Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Change From Baseline in Concentration of Lipids in the Blood
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Change From Baseline in Concentration of Apolipoproteins in the Blood
timeFrame: Baseline, Week 4 and Week 8
measure: Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood
timeFrame: Baseline, Week 4 and Week 8
Other outcomes:
Locations:
city: Noda
country: Japan
state: Chiba
city: Koga
country: Japan
state: Ibaragi
city: Moriguchi
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Fujimi
country: Japan
state: Saitama
city: Mitaka
country: Japan
state: Tokyo
city: Saitama
country: Japan
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: