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Exploratory study of the effects of omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Hyperlipidemia
Date of first enrollment	21/07/2016
Target sample size	53
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Group treated with TAK-085 2g INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational material : A dose of 2 g of omega-3-acid ethyl esters is orally administered immediately after meal twice a daily. control material(s) Generic name etc : Group not treated with TAK-085 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : HMG-CoA reductase inhibitor will be continued at the same dose regimen as at the time of informed consent.

Outcome(s)

Primary Outcome

Change in mean particle sizes of small dense LDL (sdLDL)-C and LDL-C Primary timeframe: 8 weeks Change in mean particle sizes of sdLDL-C and LDL-C collected at Week 8 or final visit relative to baseline. SdLDL is one kind of lipoproitein which is a small particle with the mean diameter of =<25.5 nm.

Secondary Outcome

1)Change from Baseline in Mean Concentration of Chylomicrons, Very low density lipoprotein (VLDL), Low density lipoprotein (LDL), and High density lipoprotein (HDL) for major lipid constituents 2)Change from Baseline in Mean Concentration of fatty acids and sdLDL-C in total lipids 3)Change in concentration and particle number of lipids, apoprotein and lipoprotein in the blood Secondary timeframe: 8 weeks 1) Change at Week 4 and Week 8 from baseline in mean concentration of major lipid constituents calculated for each major lipid constituents. The major lipid constituents include 4 Classes which are Chylomicrons, VLDL, LDL, and HDL. 2) Change at Week 4 and Week 8 from baseline in mean concentration of fatty acids and sdLDL-C in total lipids calculated. 3) Change at Week 4 and Week 8 from baseline in mean concentration and particle number of lipids, apoprotein and lipoprotein in the blood calculated.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Patients diagnosed as hyperlipidemia. 2.Patients constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the time of informed consent. 3.Patients with fasting TG of 150=< to <400 mg/dL measured at the time of informed consent at Visit 1 (Week -4). 4.Patients 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.Patients who can provide written informed consent prior to the conduction of the clinical study procedures. 6.Patients aged >=20 years at the time of informed consent at Visit 1 (Week -4).
Exclude criteria	1.Patients 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 informed consent, or those who concurrently have the above disorders. 2.Patients who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to informed consent, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder. 3.Patients in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to informed consent. 4.Patients who received an EPA preparation or an EPA/DHA preparation (including supplements) within 12 weeks prior to informed consent. 5.Patients who started antidyslipidemic agents within 4 weeks prior to informed consent. 6.Patients with severe hepatic impairment (e.g., Child-Pugh classification C) 7.Patients who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency. 8.Patients who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia. 9.Diabetic patients who are currently receiving thiazolidine or insulin. 10.Patients who are concurrently having hypertension of grade III. Note 1: Patients with systolic blood pressure of >=180 mm Hg or diastolic blood pressure of >=110 mm Hg regardless of treatment with antihypertensive drugs. 11.Patients who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol), or patients with or with a history of drug abuse or addiction. 12.Pregnant, lactating or postmenopausal women. 13.Patients with a history of hypersensitivity or allergy for omega-3-acid ethyl esters. 14.Patients participating in other clinical studies 15.Patients assessed ineligible in the study by the principal investigator or the investigator