HyperlipidemiaPhase 4Oasis FlowNCT02824432
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
A Phase 4 study testing TAK-085 in people with Hyperlipidemia, run by Takeda at 4 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- TAK-085
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesJapan
- Study dates
- 4 Aug 2016to 19 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Kagoshima
Study site
Ōita
Study site
Shinjuku, Tokyo
Study site
Yufu, Oita Prefecture
About this study
Official title: Exploratory Study of the Effect of Omega-3-acid Ethyl Esters 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.
Read the detailed 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.
- Conditions
- Hyperlipidemia
- Being tested
- TAK-085
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-085Drug
TAK-085 capsules
| Study group | Role | What they receive |
|---|---|---|
| TAK-085 2g | Experimental | A dose of 2 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered once a day immediately after meal. Receives: Drug: TAK-085 |
| TAK-085 4g | Experimental | A dose of 4 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered twice a day immediately after meal. Receives: Drug: TAK-085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated Dilation (FMD) With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4, and Week 8
Change From Baseline in FMD With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in FMD With Fasting State 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Secondary outcomes (32)
FMD With 4-Hours Postprandial State 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.
Measured: 4-hours after meal at Baseline and Week 8
Change From Baseline in FMD With 4-Hours Postprandial State at 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.
Measured: 4-hours after meal at Baseline and Week 8
Percent Change From Baseline in FMD With 4-Hours Postprandial State at 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.
Measured: 4-hours after meal at Baseline and Week 8
Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8
Measured: Prior to meal at Baseline, Week 4, and Week 8
Change From Baseline in TG Level With Fasting State at Week 4 and Week 8
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8
Measured: Prior to meal at Baseline and Week 4, and Week 8
TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8
Measured: 4-hours after meal at Baseline, Week 4, and Week 8
Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8
Measured: 4-hours after meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8
Measured: 4-hours after meal at Baseline and Week 4, and Week 8
Dihomo-gamma-linolenic Acid Concentration With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4 and Week 8
Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Arachidonic Acid Concentration With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4 and Week 8
Change From Baseline in Arachidonic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Eicosapentaenoic Acid Concentration With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4 and Week 8
Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Docosahexaenoic Acid Concentration With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4 and Week 8
Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4 and Week 8
Change From Baseline in EPA/AA Ratio With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in EPA/AA Ratio With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State 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.
Measured: Prior to meal at Baseline, Week 4 and Week 8
Change From Baseline in DHA/AA Ratio With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in DHA/AA Ratio With Fasting State at 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.
Measured: Prior to meal at Baseline and Week 4, and Week 8
Number of Participants Reporting One or More Adverse Events (AEs)
Measured: Up to Week 8
Number of Participants Reporting One or More AEs Related to Body Weight
Measured: Up to Week 8
Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position
Measured: Up to Week 8
Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position
Measured: Up to Week 8
Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start4 Aug 2016
- Primary completion19 Aug 2017
- Study completion19 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824432
- Sponsor's protocol ID
- TAK-085-4001
- Other IDs
- U1111-1182-6745, JapicCTI-163269
- Acronym
- Oasis Flow
- Status last verified
- Jan 2019
- First submitted
- 20 May 2016
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Publications
Teramoto T, Shibata H, Suzaki Y, Matsui S, Uemura N, Tomiyama H, Yamashina A. Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia. Adv Ther. 2020 May;37(5):2169-2183. doi: 10.1007/s12325-020-01286-1. Epub 2020 Mar 21.
PubMed 32200533
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
- ClinicalTrials.gov ID
- NCT02824432
- Acronym / sponsor ID
- Oasis Flow / TAK-085-4001
- Conditions
- Hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 19 Aug 2017 (actual)
- Study completion
- 19 Aug 2017 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-085 2g | Experimental | Drug: TAK-085A dose of 2 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered once a day immediately after meal. |
| TAK-085 4g | Experimental | Drug: TAK-085A dose of 4 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered twice a day immediately after meal. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-085TAK-085 capsules | Drug | TAK-085 2g, TAK-085 4g |
Primary outcome
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.
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.
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.
32 secondary outcomes
FMD With 4-Hours Postprandial State at Baseline and Week 8
Time frame: 4-hours after meal at Baseline and Week 8
Change From Baseline in FMD With 4-Hours Postprandial State at Week 8
Time frame: 4-hours after meal at Baseline and Week 8
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of Participants Reporting One or More Adverse Events (AEs)
Time frame: Up to Week 8
Number of Participants Reporting One or More AEs Related to Body Weight
Time frame: Up to Week 8
Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position
Time frame: Up to Week 8
Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position
Time frame: Up to Week 8
Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose
Time frame: Up to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32200533Teramoto T, Shibata H, Suzaki Y, Matsui S, Uemura N, Tomiyama H, Yamashina A. Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia. Adv Ther. 2020 May;37(5):2169-2183. doi: 10.1007/s12325-020-01286-1. Epub 2020 Mar 21.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAK-085 in people with Hyperlipidemia, run by Takeda at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.