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Completed

NCT Number: NCT02824432

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yufu, Oita Prefecture, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement
  • 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)
  • 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)
  • Male or postmenopausal female participants
  • 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.
  • Participants who can provide written informed consent prior to the conduction of the clinical research procedures
  • 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

  • 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)
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • Participants with severe hepatic dysfunction
  • Participants with severe renal dysfunction (as an indicator, CKD category ≥G3b, equivalent to an A3)
  • Participants who have been diagnosed with pancreatitis
  • Participants who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia
  • Participants with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism
  • Participants with symptomatic Peripheral Arterial Disease (PAD)
  • 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
  • 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)
  • Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters-
  • Participants who smoke
  • Participants participating in other clinical studies
  • Participants who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator

Treatment and study plan

TAK-085

Drug

TAK-085 capsules

Primary outcomes

  1. Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4, and Week 8

    FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

  2. Change From Baseline in FMD With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

  3. Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Secondary outcomes

  1. FMD With 4-Hours Postprandial State at Baseline and Week 8

    Time frame: 4-hours after meal at Baseline and Week 8

    FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

  2. Change From Baseline in FMD With 4-Hours Postprandial State at Week 8

    Time frame: 4-hours after meal at Baseline and Week 8

    FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

  3. Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8

    Time frame: 4-hours after meal at Baseline and Week 8

    FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

  4. Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8

    Time frame: Prior to meal at Baseline, Week 4, and Week 8

  5. Change From Baseline in TG Level With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

  6. Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

  7. TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8

    Time frame: 4-hours after meal at Baseline, Week 4, and Week 8

  8. Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8

    Time frame: 4-hours after meal at Baseline and Week 4, and Week 8

  9. Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8

    Time frame: 4-hours after meal at Baseline and Week 4, and Week 8

  10. Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4 and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

  11. Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.

  12. Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.

  13. Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4 and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

  14. Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.

  15. Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.

  16. Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4 and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

  17. Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.

  18. Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.

  19. Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4 and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

  20. Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.

  21. Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.

  22. Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4 and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.

  23. Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.

  24. Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.

  25. Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8

    Time frame: Prior to meal at Baseline, Week 4 and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.

  26. Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.

  27. Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8

    Time frame: Prior to meal at Baseline and Week 4, and Week 8

    Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.

  28. Number of Participants Reporting One or More Adverse Events (AEs)

    Time frame: Up to Week 8

  29. Number of Participants Reporting One or More AEs Related to Body Weight

    Time frame: Up to Week 8

  30. Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position

    Time frame: Up to Week 8

  31. Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position

    Time frame: Up to Week 8

  32. Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose

    Time frame: Up to Week 8

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Acronym: Oasis Flow

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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