Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation (Oasis Flow)

Takeda

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia

Treatments: Drug: TAK-085

Study type: Interventional

Funder types: Industry

Identifiers

NCT02824432

U1111-1182-6745 (Other Identifier)

JapicCTI-163269 (Registry Identifier)

TAK-085-4001

Details and patient eligibility

About

The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.

Full description

This is a multicenter, collaborative, randomized, open-label study designed to explore the effects of administration of omega-3-acid ethyl esters (TAK-085) [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.

Considering the potential bias by factors that affect FMD between treatment groups, stratified allocation will be performed with fasting triglyceride (TG) level as a factor.

Enrollment: 37 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement
2. Participants with a fasting 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. Participants 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 participants
5. Participants 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. Participants who can provide written informed consent prior to the conduction of the clinical research procedures
7. Participants aged ≥20 years at the time of informed consent at Visit 1(Day -28 to Day 0 before the start of study drug administration)

Exclusion criteria

1. Participants 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. Participants 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. Participants 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. Participant 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. Participants 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. Participants 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. Participants 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. Participants with severe hepatic dysfunction
9. Participants with severe renal dysfunction (as an indicator, CKD category ≥G3b, equivalent to an A3)
10. Participants who have been diagnosed with pancreatitis
11. Participants who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia
12. Participants with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism
13. Participants with symptomatic Peripheral Arterial Disease (PAD)
14. Participants with concurrent hypertension of grade II or higher Note 1) Note 1: Participants with systolic blood pressure of ≥160 mm Hg or diastolic BP of ≥100 mm Hg regardless of treatment with antihypertensive drugs
15. 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 Note 2)
16. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters-
17. Participants who smoke
18. Participants participating in other clinical studies
19. Participants who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

TAK-085 2g

Experimental group

Description:

A dose of 2 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered once a day immediately after meal.

Treatment:

Drug: TAK-085

TAK-085 4g

Experimental group

Description:

A dose of 4 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered twice a day immediately after meal.

Treatment:

Drug: TAK-085