Exploratory study of the effect of omega-3-acid ethyl esters on vascular endothelial function in patients with hyperlipidemia by flow mediated dilation
Exploratory study of the effect of omega-3-acid ethyl esters on vascular endothelial function in patients with hyperlipidemia by flow mediated dilation
version:
date:
Takeda Pharmaceutical Company Limited
https://www.takeda.co.jp/contact/form/jp/form/
37
Interventional
This is a multicenter, collaborative, randomized, open-label study designed to explore the effects of administration of omega-3-acid ethyl esters [2 g (2 g PO QD) or 4 g (2 g PO BID) for 8 weeks] on vascular endothelial function, as measured by flow-mediated dilation (FMD), in patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and have concurrent hypertriglyceridemia (hereinafter referred to as TG).
Considering the potential bias by factors that affect FMD between treatment groups, stratified allocation will be performed with fasting TG level as a factor.
4
1. Patients with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement
2. Patients with a fasting triglyceride (TG) level of 150 -499 mg/dL at Visit 1 after informed consent (Day -29 to Day -1 before start of study drug administration)
3. Patients receiving a stable dose of HMG-CoA reductase inhibitor therapy continuously for at least 4 weeks before informed consent at Visit 1 (Day -29 to Day -1 before start of study drug administration)
4. Male or postmenopausal female patients
5. Patients who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
6. Patients who can provide written informed consent prior to the conduction of the clinical research procedures
7. Patients aged >=20 years at the time of informed consent at Visit 1(Day -28 to Day 0 before the start of study drug administration)
1. Patients with a history of revascularization or those have had coronary artery disease (a definitive diagnosis of myocardial infarction, angina) within 24 weeks before informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
2. Patients who have undergo aortic aneurysmectomy within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those with concurrent aortic aneurysm
3. Patients who have 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 at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those who concurrently have the above disorders
4. Patient with a fasting FMD level of 0% measured at the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)
5. Patients in whom the type and dosage of HMG-CoA reductase inhibitors, antidiabetic drugs and antihypertensive drugs have been changed within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
6. Patients who have started anti dyslipidemic agents within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
7. Patients requiring a change in the dose of dyslipidemia therapeutic, antidiabetic, or antihypertensive drugs during the period between informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) and the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)
8. Patients with severe hepatic dysfunction
9. Patients with severe renal dysfunction (as an indicator, CKD category >=G3b, equivalent to an A3)
10. Patients who have been diagnosed with pancreatitis
11. Patients who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia
12. Patients with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism
13. Patients with symptomatic Peripheral Arterial Disease (PAD)
14. Patients with concurrent hypertension of grade II or higher Note 1)
Note 1: Patients with systolic blood pressure of >=160 mm Hg or diastolic BP of >=100 mm Hg regardless of treatment with antihypertensive drugs
15. 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 Note 2)
16. Patients with a history of hypersensitivity or allergy for omega-3-acid ethyl esters-
17. Patients who smoke
18. Patients participating in other clinical studies
19. Patients who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator
20age old over
No limit
Both
Hyperlipidemia
investigational material(s)
Generic name etc : Omega-3-acid ethyl esters
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 will be orally administered once or twice a day immediately after meal.
%FMD (fasting)
Timeframe: 8 weeks
%FMD (4 h postprandial), TG level (fasting), TG level (4 h postprandial), Plasma fatty acid fraction, Adverse events, body weight, blood pressure in the sitting position, pulse in the sitting position, laboratory tests [fasting plasma glucose (FPG)]
Timeframe: 8 weeks
