HyperlipidemiaPhase 4LOTUSNCT02839902

Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood

A Phase 4 study testing TAK-085 and Not treated with omega-3-acid ethyl esters in people with Hyperlipidemia, run by Takeda at 7 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl… 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 and Not treated with omega-3-acid ethyl esters
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 7 sitesJapan
Study dates: 27 Dec 2016to 30 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 diagnosed as hyperlipidemia.
Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the start of the observation period.
Participants with fasting TG of 150≤ to <400 mg/dL measured at the start of the observation period at Visit 1 (Week -4).
Participants 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.
Participants who can provide written informed consent prior to the conduction of the clinical study procedures.
Participants aged ≥20 years at the time of informed consent at Visit 1 (Week -4).

Who cannot join

Participants 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 the start of the observation period, or those who concurrently have the above disorders.
Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to the start of the observation period, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder.
Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to the start of observation period.
Participants who received an eicosapentaenoic acid (EPA) preparation or an EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks prior to the start of observation period.
Participants who started antidyslipidemic agents within 4 weeks prior to the start of observation period.
Participants with severe hepatic impairment (e.g., Child-Pugh classification C).

Show all 15Show fewer

Participants who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency.
Participants who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia.
Diabetic participants who are currently receiving thiazolidine or insulin.
Participants who are concurrently having hypertension of grade IIINote 1). Note 1: Participants with systolic blood pressure of ≥180 mm Hg or diastolic blood pressure of ≥110 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.
Pregnant, lactating or postmenopausal women.
Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters.
Participants participating in other clinical studies.
Participants assessed ineligible in the study by the principal investigator or the investigator.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Study site
Fujimi, Saitama
Study site
Koga, Ibaragi
Study site
Mitaka, Tokyo
Study site
Moriguchi, Osaka
Study site
Noda, Chiba
Study site
Saitama
Study site
Suita, Osaka

Other trials in Japan

About this study

Read the detailed description

This study was designed to explore the effects of omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor in comparison with the control group of patients not treated with omega-3-acid ethyl esters in an unblinded manner by use of high performance liquid chromatography (HPLC) using highly-sensitive gel filtration columns, which is a technique for analyzing lipoprotein.

Study participants who gave consent and were assessed as eligible in the eligibility assessment will be stratified by the factors of "fasting triacylglycerol (TG; <300 mg/dL or 300 mg/dL≤) and age (<65 years or 65 years≤) at the start of the screening period" and allocated to either the group treated with omega-3-acid ethyl esters or the group not treated with omega-3-acid ethyl esters (1:1 ratio).

Conditions: Hyperlipidemia
Being tested: TAK-085, Not treated with omega-3-acid ethyl esters
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
Omega-3-acid ethyl esters (TAK-085) capsule
Not treated with omega-3-acid ethyl estersOther
Not treated with omega-3-acid ethyl esters

Study groups in NCT02839902
Study group	Role	What they receive
TAK-085 4g	Experimental	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule is orally administered immediately after meal twice a daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose. Receives: Drug: TAK-085
Control Group	Experimental	Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. Receives: Other: Not treated with omega-3-acid ethyl esters

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction
Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.
Measured: Baseline, Week 4, and Week 8
Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents
Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures ("Change in mean particle sizes of sdLDL-C" and "Change in mean particle sizes of LDL-C") on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density.
Measured: Baseline, Week 4, and Week 8

Secondary outcomes (13)

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in CM fraction at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in VLDL Fraction at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in LDL Fraction at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in HDL Fraction at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids
Fatty acids refer to the following 24 acids; Lauric acid, Myristic acid, Myristoleic acid, Palmitic acid, Palmitoleic acid, Stearic acid, Oleic acid, Linoleic acid, Gamma-linolenic acid, Linolenic acid, Arachic acid, Eicosenoic acid, Eicosadienoic acid, 5-8-11 Eicosatrienoic acid, Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Behenic acid, Erucic acid, Docosatetraenoic acid, Docosapentaenoic acid, Lignoceric acid, Docosahexaenoic acid, and Nervonic acid. The reported data are percent of change from baseline in concentration of these fatty acids in total lipids at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids
The reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids
The reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids
The reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids
The reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids
There were no reporting data for this outcome measure because the data of change in mean concentration of sdLDL-C in total lipids were not collected and analyzed in this study finally. So here the data input for this outcome measure are NA for each arm.
Measured: Baseline, Week 4 and Week 8
Percent Change From Baseline in Concentration of Lipids in the Blood
Lipids on this outcome measure include Total cholesterol, Triacylglycerol (TG), HDL-C, non-HDL, and Remnant lipoprotein cholesterol (RemL-C). Reported data are percent of change in concentration of these lipids in the blood at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Change From Baseline in Concentration of Apolipoproteins in the Blood
Apolipoproteins on this outcome measure include Apolipoprotein AI, AII, B, B-48, B-100, CII, CIII, CII/III, and E. Reported data are percent of change in concentration of these apolipoproteins in the blood at Week 4 and Week 8.
Measured: Baseline, Week 4 and Week 8
Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood
Reported data were percent of changes from baseline in lipoprotein particle numbers in the blood for 4 fractions (CM, VLDL, LDL, and HDL fractions). Data for this outcome measure was reported instead of the outcome measure title of "Change from Baseline in particle number of lipids, apoprotein and lipoprotein" on registration module (see History of Change of registration).
Measured: Baseline, Week 4 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 201630 Aug 2017

First posted21 Jul 2016 (estimated)
Study start27 Dec 2016
Primary completion30 Aug 2017
Study completion30 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.
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: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02839902
Sponsor's protocol ID: TAK-085-4002
Other IDs: U1111-1185-0054, JapicCTI-163322
Acronym: LOTUS
Status last verified: Aug 2018
First submitted: 19 Jul 2016
Last updated: 11 Feb 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
ClinicalTrials.gov ID: NCT02839902
Acronym / sponsor ID: LOTUS / TAK-085-4002
Conditions: Hyperlipidemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 27 Dec 2016 (actual)
Primary completion: 30 Aug 2017 (actual)
Study completion: 30 Aug 2017 (actual)
First posted: 21 Jul 2016 (estimated)
Results: Posted 11 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TAK-085 4g	Experimental	Drug: TAK-085A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule is orally administered immediately after meal twice a daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.
Control Group	Experimental	Other: Not treated with omega-3-acid ethyl estersStable HMG-CoA reductase inhibitor regimen at a consistent dose only.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participants diagnosed as hyperlipidemia.
Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the start of the observation period.
Participants with fasting TG of 150≤ to <400 mg/dL measured at the start of the observation period at Visit 1 (Week -4).
Participants 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.
Participants who can provide written informed consent prior to the conduction of the clinical study procedures.

Key exclusion criteria (15 listed)

Participants 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 the start of the observation period, or those who concurrently have the above disorders.
Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to the start of the observation period, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder.
Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to the start of observation period.
Participants who received an eicosapentaenoic acid (EPA) preparation or an EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks prior to the start of observation period.
Participants who started antidyslipidemic agents within 4 weeks prior to the start of observation period.

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-085Omega-3-acid ethyl esters (TAK-085) capsule	Drug	TAK-085 4g
Not treated with omega-3-acid ethyl estersNot treated with omega-3-acid ethyl esters	Other	Control Group

Primary outcome

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction
Time frame: Baseline, Week 4 and Week 8
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8.
Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction
Time frame: Baseline, Week 4, and Week 8
Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.
Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents
Time frame: Baseline, Week 4, and Week 8
Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures ("Change in mean particle sizes of sdLDL-C" and "Change in mean particle sizes of LDL-C") on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density.

13 secondary outcomes

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids
Time frame: Baseline, Week 4 and Week 8
Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids
Time frame: Baseline, Week 4 and Week 8
Percent Change From Baseline in Concentration of Lipids in the Blood
Time frame: Baseline, Week 4 and Week 8
Percent Change From Baseline in Concentration of Apolipoproteins in the Blood
Time frame: Baseline, Week 4 and Week 8
Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood
Time frame: Baseline, Week 4 and Week 8

Results and safety

Results posted to the registry on 11 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-085 4 g	24	24
Control Group	29	29

Primary outcome: Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction

Time frame: Baseline, Week 4 and Week 8. Mean (Standard Deviation). Unit: Percent of Change

Measure	TAK-085 4 g n = 24	Control Group n = 29
Cholesterol at Week 4	-6.50 (15.745)	5.05 (11.401)
Cholesterol at Week 8	-12.35 (13.519)	4.64 (17.845)
Triglycerides at Week 4	-2.87 (22.917)	9.71 (23.437)
Triglycerides at Week 8	-6.50 (22.615)	2.74 (20.317)
Free Cholesterol at Week 4	-6.32 (12.483)	2.14 (14.048)
Free Cholesterol at Week 8	-6.94 (16.639)	3.42 (14.516)
Phospholipid at Week 4	-8.31 (11.396)	2.10 (11.297)
Phospholipid at Week 8	-10.37 (13.919)	1.09 (13.440)

TAK-085 4 g vs Control Group: Least square (LS) mean difference: -17.147 (95% CI -26.344 to -7.950), p = 0.0004, ANCOVA
TAK-085 4 g vs Control Group: Least square (LS) mean difference: -9.774 (95% CI -21.986 to 2.439), p = 0.1141, ANCOVA
TAK-085 4 g vs Control Group: Least square (LS) mean difference: -10.246 (95% CI -19.143 to -1.349), p = 0.0248, ANCOVA

Population analysed: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Primary outcome: Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction

Time frame: Baseline, Week 4, and Week 8. Mean (Standard Deviation). Unit: Percent of Change

Measure	TAK-085 4 g n = 24	Control Group n = 29
Week 4	4.48 (21.423)	5.66 (25.908)
Week 8	8.64 (31.398)	-0.94 (17.267)

TAK-085 4 g vs Control Group: Least square (LS) mean difference: 9.499 (95% CI -4.623 to 23.622), p = 0.1826, ANCOVA

Population analysed: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Primary outcome: Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents

Time frame: Baseline, Week 4, and Week 8. Mean (Standard Deviation). Unit: Percent of Change

Measure	TAK-085 4 g n = 24	Control Group n = 29
Week 4 (Cholesterol Monitor)	0.56 (1.217)	-0.39 (0.820)
Week 8 (Cholesterol Monitor)	0.99 (1.192)	-0.08 (1.274)
Week 4 (Triglycerides Monitor)	0.87 (6.026)	-0.06 (1.367)
Week 8 (Triglycerides Monitor)	2.11 (2.715)	0.52 (3.155)
Week 4 (Free Cholesterol Monitor)	0.79 (1.247)	-0.16 (0.953)
Week 8 (Free Cholesterol Monitor)	0.90 (1.407)	0.07 (1.361)
Week 4 (Phospholipid Monitor)	0.63 (1.464)	-0.23 (1.018)
Week 8 (Phospholipid Monitor)	0.99 (1.316)	0.09 (1.431)

TAK-085 4 g vs Control Group: Least square (LS) mean difference: 1.066 (95% CI 0.356 to 1.776), p = 0.0040, ANCOVA
TAK-085 4 g vs Control Group: Least square (LS) mean difference: 1.553 (95% CI -2.884 to 5.991), p = 0.4428, ANCOVA
TAK-085 4 g vs Control Group: Least square (LS) mean difference: 0.760 (95% CI -0.024 to 1.544), p = 0.0570, ANCOVA

Population analysed: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 8. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-085 4 g	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Control Group	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Medical Director study director

Takeda

7 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 and Not treated with omega-3-acid ethyl esters in people with Hyperlipidemia, run by Takeda at 7 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 6 inclusion and 15 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 11 Feb 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?

Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction (time frame: 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 NCT02839902.

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 11 Feb 2019.