CClinicalTrials.gg
Sign In
CompletedNCT01350999Updated Sep 20, 2016Results posted

Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia

A Phase 3 interventional study of omega-3-acid ethyl esters 90 (TAK-085) and Eicosapentaenoic acid-ethyl (EPA) in Hypertriglyceridemia, sponsored by Takeda. Completed. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
503
Allocation
Randomized
Ages
20 Years to 74 Years
Sex
All
01

Study summary

The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Read the detailed description

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.

02

Conditions studied

  • Hypertriglyceridemia

Browse trials for

Keywords

  • Drug Therapy
03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 503 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Visit 1 (Week -4)

  1. Undergoing lifestyle modification.
  2. Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
  3. Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
  4. Outpatient.
  5. Capable of understanding and complying with protocol requirements.
  6. Signed a written, informed consent form prior to the initiation of any study procedures.

  7. A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

    Visit 2 (Week -2)

  8. Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
  9. Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value

Exclusion criteria

Exclusion Criteria:

Visit 1 (Week -4)

  1. Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
  2. Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
  3. History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
  4. Diagnosed with pancreatitis.
  5. Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
  6. Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
  7. Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
  8. Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
  9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
  10. If female, was pregnant or lactating.
  11. Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
  12. Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
  13. Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
  14. Received TAK-085 in a clinical study.

  15. Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.

    Visit 2 (Week -2)

  16. ALT or AST level at Visit 2 (Week -2) was twice the upper limit of the normal reference range or higher.
  17. Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.

  18. Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.

    Visit 3 (Week 0)

  19. Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
  20. Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
503 participants (actual)

Study arms

  • Experimental
    TAK-085 2 g

    TAK-085 2 g, orally, once daily for up to 52 weeks.

    Drug: omega-3-acid ethyl esters 90 (TAK-085)

  • Experimental
    TAK-085 4 g

    TAK-085 2 g, orally, twice daily for up to 52 weeks.

    Drug: omega-3-acid ethyl esters 90 (TAK-085)

  • Active comparator
    EPA-E 1.8 g

    Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.

    Drug: Eicosapentaenoic acid-ethyl (EPA)

Interventions

  • Drugomega-3-acid ethyl esters 90 (TAK-085)

    Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.

    Also known as: LOVAZA, Omacor

  • DrugEicosapentaenoic acid-ethyl (EPA)

    EPA-E capsules

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 52 Weeks

  2. Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs

    Time frame: 52 Weeks

  3. Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight

    Time frame: 52 Weeks

  4. Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration

    Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.

    Time frame: 52 Weeks

  5. Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis

    Time frame: 52 Weeks

Secondary outcomes

  1. Percent Change From Baseline in Triglyceride Level

    Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  2. Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)

    Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  3. Percent Change From Baseline in Total Cholesterol

    Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  4. Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)

    Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  5. Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol

    Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.

    Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

07

Results

Posted Sep 20, 2016

Participant flow

Participants took part in the study at 50 investigative sites in Japan from 11 November 2009 to 11 January 2011.

Participant flow — Overall Study
MilestoneTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Started165171167
Treated165171167
Completed157157146
Not completed81421
Withdrew: Adverse event4910
Withdrew: Voluntary withdrawal346
Withdrew: Difficulty making it to study visit115

Outcome measures

PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame:
52 Weeks
Reported as:
Number · participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
participantsTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Number of Participants With Treatment Emergent Adverse Events (TEAEs)106110109
PrimaryNumber of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Time frame:
52 Weeks
Reported as:
Number · participants
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
participantsTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs0 ± 12.580 ± 12.640 ± 12.80
PrimaryNumber of Participants With TEAEs Associated With Abnormal Changes in Body Weight
Time frame:
52 Weeks
Reported as:
Number · participants
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight
participantsTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight0 ± 0.9070 ± 0.8700 ± 0.919
PrimaryNumber of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration

Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.

Time frame:
52 Weeks
Reported as:
Number · participants
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration
participantsTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration000
PrimaryNumber of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame:
52 Weeks
Reported as:
Number · participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
participantsTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis242123
SecondaryPercent Change From Baseline in Triglyceride Level
Time frame:
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Reported as:
Mean · percent change
Percent Change From Baseline in Triglyceride Level
percent changeTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Week 4 (n=163, 168, 166)-10.875 ± 28.1914-24.550 ± 26.7987-5.743 ± 35.8469
Week 8 (n=162, 166, 163)-10.474 ± 36.1225-26.555 ± 24.1354-5.796 ± 36.2369
Week 12 (n=162, 166, 161)-11.628 ± 28.6330-21.689 ± 27.9188-9.204 ± 34.5555
Week 16 (n=160, 165, 161)-9.363 ± 35.5523-20.735 ± 35.0625-9.522 ± 36.2768
Week 20 (n=161, 164, 157)-12.965 ± 29.2649-21.483 ± 28.1817-7.400 ± 37.9737
Week 24 (n=158, 162, 155)-13.393 ± 34.8938-23.863 ± 31.2129-8.269 ± 38.8420
Week 28 (n=159, 159, 153)-12.644 ± 33.3250-25.119 ± 31.4602-9.422 ± 34.4423
Week 32 (n=159, 160, 151)-11.464 ± 36.7968-27.219 ± 27.8708-9.867 ± 36.9807
Week 36 (n=156, 158, 151)-16.190 ± 33.2777-26.535 ± 27.0283-9.616 ± 42.1895
Week 40 (n=159, 158, 151)-13.934 ± 35.8353-25.062 ± 30.7020-15.345 ± 33.6494
Week 44 (n=158, 156, 149)-17.156 ± 31.8849-24.402 ± 30.1719-12.363 ± 38.4921
Week 48 (n=156, 155, 147)-14.722 ± 33.1045-26.478 ± 31.4535-10.185 ± 39.0040
Week 52 (n=153, 151, 145)-14.219 ± 31.1401-26.023 ± 28.3644-13.872 ± 40.9936
SecondaryPercent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)
Time frame:
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Reported as:
Mean · percent change
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)
percent changeTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Week 4 (n=165, 170, 167)-2.219 ± 14.5984-2.327 ± 17.3965-3.018 ± 16.3629
Week 8 (n=164, 168, 165)-2.890 ± 15.7779-3.209 ± 17.1870-4.423 ± 16.7481
Week 12 (n=163, 168, 161)-4.692 ± 15.5025-4.778 ± 16.2444-4.542 ± 16.6098
Week 16 (n=163, 167, 161)-4.689 ± 17.3729-4.404 ± 18.8456-4.551 ± 17.6688
Week 20 (n=162, 166, 157)-4.953 ± 16.1426-3.088 ± 17.7755-5.676 ± 17.9077
Week 24 (n=159, 164, 155)-4.232 ± 14.6688-0.768 ± 19.6396-3.623 ± 20.1695
Week 28 (n=160, 161, 153)-1.660 ± 16.94980.421 ± 22.1540-2.888 ± 17.1272
Week 32 (n=160, 163, 151)-1.961 ± 17.80591.776 ± 21.1586-1.030 ± 19.2558
Week 36 (n=158, 160, 151)-1.731 ± 16.75002.858 ± 20.93760.035 ± 20.9409
Week 40 (n=160, 160, 151)-0.378 ± 17.48482.412 ± 20.8940-0.037 ± 20.6483
Week 44 (n=160, 158, 150)1.677 ± 17.20212.334 ± 21.04400.598 ± 19.6207
Week 48 (n=157, 157, 148)-0.634 ± 16.29262.413 ± 22.0726-0.306 ± 19.0464
Week 52 (n=155, 154, 145)-0.374 ± 17.55982.993 ± 20.3400-0.621 ± 16.9016
SecondaryPercent Change From Baseline in Total Cholesterol
Time frame:
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Reported as:
Mean · percent change
Percent Change From Baseline in Total Cholesterol
percent changeTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Week 4 (n=165, 170, 167)-3.347 ± 9.1943-6.381 ± 9.8008-3.386 ± 9.8537
Week 8 (n=164, 168, 165)-3.510 ± 9.3764-7.294 ± 9.7792-3.711 ± 11.0426
Week 12 (n=163, 168, 161)-4.918 ± 9.1307-7.316 ± 9.7382-5.300 ± 10.5662
Week 16 (n=163, 167, 161)-4.489 ± 10.9503-7.131 ± 10.7158-5.027 ± 12.2383
Week 20 (n=162, 166, 157)-5.310 ± 10.0187-6.543 ± 10.2848-5.421 ± 11.6463
Week 24 (n=159, 164, 155)-4.503 ± 9.5968-4.824 ± 11.2452-4.241 ± 13.3773
Week 28 (n=160, 161, 153)-2.590 ± 11.5574-4.691 ± 11.0348-3.644 ± 11.0906
Week 32 (n=160, 163, 151)-2.201 ± 11.0082-3.427 ± 11.2990-2.939 ± 11.0774
Week 36 (n=158, 160, 151)-2.418 ± 10.7162-2.439 ± 11.0752-1.980 ± 12.9512
Week 40 (n=160, 160, 151)-1.755 ± 10.7847-3.085 ± 10.7054-2.947 ± 12.9953
Week 44 (n=160, 158, 150)-1.073 ± 10.0091-2.956 ± 9.9486-2.509 ± 12.1363
Week 48 (n=157, 157, 148)-2.581 ± 9.8592-3.435 ± 11.1554-2.406 ± 11.8012
Week 52 (n=155, 154, 145)-2.066 ± 10.9462-2.801 ± 11.0523-2.808 ± 10.6534
SecondaryPercent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)
Time frame:
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Reported as:
Mean · percent change
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)
percent changeTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Week 4 (n=165, 170, 167)0.849 ± 12.28142.184 ± 12.6361-0.762 ± 11.4762
Week 8 (n=164, 168, 165)1.886 ± 13.66791.298 ± 12.8820-0.955 ± 12.9760
Week 12 (n=163, 168, 161)0.535 ± 12.56941.085 ± 13.1746-0.561 ± 12.7619
Week 16 (n=163, 167, 161)1.276 ± 13.39751.699 ± 12.4080-0.134 ± 12.7453
Week 20 (n=162, 166, 157)2.708 ± 14.73062.913 ± 13.32321.034 ± 14.0619
Week 24 (n=159, 164, 155)4.569 ± 14.82515.684 ± 14.71412.693 ± 14.7185
Week 28 (n=160, 161, 153)4.712 ± 16.00766.117 ± 15.52202.975 ± 15.7048
Week 32 (n=160, 163, 151)6.456 ± 16.23786.890 ± 14.64593.012 ± 14.6151
Week 36 (n=158, 160, 151)8.234 ± 15.87498.516 ± 14.26414.946 ± 15.6107
Week 40 (n=160, 160, 151)8.410 ± 18.03648.359 ± 15.62015.264 ± 15.6110
Week 44 (n=160, 158, 150)7.983 ± 15.53137.182 ± 15.72274.533 ± 14.3921
Week 48 (n=157, 157, 148)6.191 ± 14.70707.144 ± 15.14334.499 ± 14.6233
Week 52 (n=155, 154, 145)6.738 ± 15.36296.932 ± 16.17965.183 ± 14.7508
SecondaryPercent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol

Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.

Time frame:
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Reported as:
Mean · percent change
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol
percent changeTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Week 4 (n=165, 170, 167)-4.406 ± 11.2322-8.831 ± 12.2172-3.885 ± 12.3062
Week 8 (n=164, 168, 165)-4.836 ± 11.6718-9.663 ± 11.6911-4.185 ± 13.9301
Week 12 (n=163, 168, 161)-6.355 ± 11.1879-9.665 ± 11.8662-6.301 ± 12.7396
Week 16 (n=163, 167, 161)-5.929 ± 13.2860-9.674 ± 13.2498-6.102 ± 15.3247
Week 20 (n=162, 166, 157)-7.329 ± 12.1200-9.169 ± 12.6390-6.941 ± 14.3629
Week 24 (n=159, 164, 155)-6.911 ± 11.1228-7.769 ± 13.3944-5.842 ± 15.4628
Week 28 (n=160, 161, 153)-4.396 ± 13.6832-7.643 ± 13.3578-5.219 ± 13.4854
Week 32 (n=160, 163, 151)-4.373 ± 13.3296-6.273 ± 14.3110-4.186 ± 13.7872
Week 36 (n=158, 160, 151)-5.256 ± 13.2490-5.515 ± 14.4721-3.574 ± 16.2259
Week 40 (n=160, 160, 151)-4.285 ± 14.7340-6.397 ± 14.1767-4.907 ± 16.5866
Week 44 (n=160, 158, 150)-3.270 ± 12.4442-5.801 ± 13.3310-4.134 ± 15.6056
Week 48 (n=157, 157, 148)-4.796 ± 12.2273-6.497 ± 14.6818-4.088 ± 15.0735
Week 52 (n= 155, 154, 145)-4.340 ± 13.7408-5.255 ± 14.9219-4.830 ± 13.5956

Adverse events

Collected over Collection of AEs commenced from the time that the participant was first administered investigational product (Week 0) until the completion of study treatment (52 weeks of administration). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAK-085 2 g—5/165 (3%)96/165 (58.2%)
TAK-085 4 g—10/171 (5.8%)94/171 (55%)
EPA-E 1.8 g—7/167 (4.2%)104/167 (62.3%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
Peritonsillar abscessInfections and infestations1/1650/1710/167
Large intestine carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1650/1710/167
DehydrationMetabolism and nutrition disorders1/1650/1710/167
Atrial fibrillationCardiac disorders1/1650/1710/167
Neurogenic shockVascular disorders1/1650/1710/167
Sleep apnoea syndromeRespiratory, thoracic and mediastinal disorders1/1650/1710/167
PneumoniaInfections and infestations0/1650/1711/167
Cervix carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1650/1711/167
SchizophreniaPsychiatric disorders0/1650/1711/167
Autonomic nervous system imbalanceNervous system disorders0/1650/1711/167
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTAK-085 2 gTAK-085 4 gEPA-E 1.8 g
NasopharyngitisInfections and infestations57/16543/17142/167
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders12/16519/17114/167
Blood creatine phosphokinase increasedInvestigations13/1657/17118/167
PharyngitisInfections and infestations14/16515/17115/167
Back painMusculoskeletal and connective tissue disorders7/1658/17112/167
Liver function test abnormalInvestigations10/1657/1716/167
BronchitisInfections and infestations9/1657/1719/167
Seasonal allergyImmune system disorders6/1656/1719/167
Diabetes mellitusMetabolism and nutrition disorders3/1659/1719/167
DiarrhoeaGastrointestinal disorders8/1659/1719/167

Baseline characteristics

Age, Continuous
Age, Continuous(years)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
Mean56.0 ± 10.9555.9 ± 10.1255.8 ± 9.2755.9 ± 10.11
Age, Customized
Age, Customized(participants)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
≥20 - <65 years119134136389
≥65 - ≤74 years463731114
Sex: Female, Male
Sex: Female, Male(Participants)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
Female475048145
Male118121119358
Region of Enrollment
Region of Enrollment(participants)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
Japan165171167503
Menopause Status
Menopause Status(participants)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
Yes384239119
No57517
Unknown4149
Not Applicable118121119358
Height, Categorical
Height, Categorical(participants)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
<160 cm484548141
≥160 - <170 cm677766210
≥170 cm504953152
Height
Height(cm)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
Mean164.2 ± 9.40164.0 ± 8.69164.4 ± 9.65164.2 ± 9.23
Weight, Categorical
Weight, Categorical(participants)TAK-085 2 gTAK-085 4 gEPA-E 1.8 gTotal
<60 kg32343298
≥60.0 - <70.0 kg575343153
≥70.0 - <80.0 kg445057151
≥80.0 kg323435101

15 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01350999
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
May 10, 2011
Start date
Nov 2009
Primary completion
Jan 2011
Completion
Jan 2011
Results posted
Sep 20, 2016
Last update
Sep 20, 2016

Study contacts

Associate Professor, Clinical Cell Biology and Medicine
study director · Graduate School of Medicine, Chiba University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertriglyceridemia→

Other studies from this sponsor

Takeda

Start the discussion