Hypertriglyceridemia
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study was to determine the efficacy and safety 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.
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, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification. The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.
Interventions
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.
DRUGEicosapentaenoic acid-ethyl (EPA-E)
EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one. 2. Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.
Exclusion criteria
1. Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization. 2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8). 3. Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8). 4. Participants who have been diagnosed with pancreatitis. 5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia. 6. Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Triglyceride Level at the Final Visit | Baseline and 12 weeks | The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Baseline and Weeks 4, 8, 10 and 12 | The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance. |
| Percent Change From Baseline in Total Cholesterol Over Time | Baseline and Weeks 4, 8, 10 and 12 | The percentage change between total cholesterol measured at each study visit relative to Baseline. |
| Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Baseline and Weeks 4, 8, 10 and 12 | The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline. |
| Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Baseline and Weeks 4, 8, 10 and 12 | The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol. |
| Percent Change From Baseline in Triglyceride Level Over Time | Baseline and Weeks 4, 8, 10 and 12 | The percentage change between triglycerides collected at each study visit relative to Baseline. |
| Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | 12 Weeks | — |
| Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 12 Weeks | — |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration | 12 Weeks | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 12 Weeks | — |
Participant flow
Recruitment details
Participants took part in the study at 69 investigational sites in Japan from 21 November 2009 to 28 December 2010.
Pre-assignment details
Participants with hypertriglyceridemia were randomized to receive omega-3-acid ethyl esters 90 (TAK-085) 2 g once daily or TAK-085 2 g twice daily or EPA-E 0.6 g three-times daily.
Participants by arm
| Arm | Count |
|---|---|
| TAK-085 2 g TAK-085 2 g, orally, once daily for up to 12 weeks. | 206 |
| TAK-085 4 g TAK-085 2 g, orally, twice daily for up to 12 weeks. | 210 |
| EPA-E 1.8 g Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. | 195 |
| Total | 611 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 7 | 7 |
| Overall Study | Voluntary Withdrawal | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | EPA-E 1.8 g | TAK-085 4 g | TAK-085 2 g |
|---|---|---|---|---|
| Administration of 3-hydroxy 3-methylglutaryl coenzyme A (HMGCoA) Reductase Inhibitor No | 350 participants | 112 participants | 121 participants | 117 participants |
| Administration of 3-hydroxy 3-methylglutaryl coenzyme A (HMGCoA) Reductase Inhibitor Yes | 261 participants | 83 participants | 89 participants | 89 participants |
| Age, Continuous | 54.8 years STANDARD_DEVIATION 10.6 | 55.6 years STANDARD_DEVIATION 10.52 | 55.0 years STANDARD_DEVIATION 10.5 | 53.9 years STANDARD_DEVIATION 10.76 |
| Age, Customized ≥20 - <65 years | 485 participants | 148 participants | 169 participants | 168 participants |
| Age, Customized ≥65 - ≤74 years | 126 participants | 47 participants | 41 participants | 38 participants |
| Body Mass Index | 26.38 kg/m^2 STANDARD_DEVIATION 3.71 | 26.34 kg/m^2 STANDARD_DEVIATION 3.628 | 26.26 kg/m^2 STANDARD_DEVIATION 3.846 | 26.55 kg/m^2 STANDARD_DEVIATION 3.658 |
| Body Mass Index (BMI), Categorical ≥25.0 - <30.0 kg/m^2 | 286 participants | 99 participants | 93 participants | 94 participants |
| Body Mass Index (BMI), Categorical <25.0 kg/m^2 | 233 participants | 69 participants | 89 participants | 75 participants |
| Body Mass Index (BMI), Categorical ≥30.0 kg/m^2 | 91 participants | 27 participants | 28 participants | 36 participants |
| Coronary Artery Disease (CAD) Category Category I | 25 participants | 4 participants | 15 participants | 6 participants |
| Coronary Artery Disease (CAD) Category Category II | 244 participants | 79 participants | 70 participants | 95 participants |
| Coronary Artery Disease (CAD) Category Category III | 336 participants | 110 participants | 124 participants | 102 participants |
| Coronary Artery Disease (CAD) Category History of CAD | 6 participants | 2 participants | 1 participants | 3 participants |
| Diabetes Mellitus (Including Impaired Glucose Tolerance) No | 412 participants | 128 participants | 140 participants | 144 participants |
| Diabetes Mellitus (Including Impaired Glucose Tolerance) Yes | 199 participants | 67 participants | 70 participants | 62 participants |
| Height | 165.7 cm STANDARD_DEVIATION 8.69 | 166.0 cm STANDARD_DEVIATION 8.89 | 165.7 cm STANDARD_DEVIATION 8.64 | 165.5 cm STANDARD_DEVIATION 8.6 |
| Height, Categorical ≥160 - <170 cm | 255 participants | 78 participants | 86 participants | 91 participants |
| Height, Categorical <160 cm | 139 participants | 41 participants | 49 participants | 49 participants |
| Height, Categorical ≥170 cm | 217 participants | 76 participants | 75 participants | 66 participants |
| Hypertension No | 230 participants | 64 participants | 83 participants | 83 participants |
| Hypertension Yes | 381 participants | 131 participants | 127 participants | 123 participants |
| Low Density Lipoprotein - Cholesterol (LDL-C) | 127.7 mg/dL STANDARD_DEVIATION 29.37 | 130.1 mg/dL STANDARD_DEVIATION 30.54 | 125.7 mg/dL STANDARD_DEVIATION 28.5 | 127.4 mg/dL STANDARD_DEVIATION 29.08 |
| Low Density Lipoprotein - Cholesterol (LDL-C), Categorical <140 mg/dL | 413 participants | 124 participants | 149 participants | 140 participants |
| Low Density Lipoprotein - Cholesterol (LDL-C), Categorical ≥140 mg/dL | 197 participants | 71 participants | 61 participants | 65 participants |
| Low High Density Lipoprotein - Cholesterol (HDL-C) No | 437 participants | 135 participants | 154 participants | 148 participants |
| Low High Density Lipoprotein - Cholesterol (HDL-C) Yes | 174 participants | 60 participants | 56 participants | 58 participants |
| Menopause Status No | 20 participants | 6 participants | 6 participants | 8 participants |
| Menopause Status Not Applicable | 482 participants | 158 participants | 162 participants | 162 participants |
| Menopause Status Yes | 109 participants | 31 participants | 42 participants | 36 participants |
| Region of Enrollment Japan | 611 participants | 195 participants | 210 participants | 206 participants |
| Sex: Female, Male Female | 137 Participants | 38 Participants | 53 Participants | 46 Participants |
| Sex: Female, Male Male | 474 Participants | 157 Participants | 157 Participants | 160 Participants |
| Smoking Classification Current Smoker | 223 participants | 69 participants | 76 participants | 78 participants |
| Smoking Classification Ex-Smoker | 208 participants | 72 participants | 68 participants | 68 participants |
| Smoking Classification Never Smoked | 180 participants | 54 participants | 66 participants | 60 participants |
| Triglycerides | 272.8 mg/dL STANDARD_DEVIATION 89.12 | 271.8 mg/dL STANDARD_DEVIATION 91.53 | 277.5 mg/dL STANDARD_DEVIATION 97.29 | 269.0 mg/dL STANDARD_DEVIATION 77.52 |
| Triglycerides, Categorical ≥150 - <300 mg/dL | 424 participants | 135 participants | 146 participants | 143 participants |
| Triglycerides, Categorical <150 mg/dL | 1 participants | 1 participants | 0 participants | 0 participants |
| Triglycerides, Categorical ≥300 - <500 mg/dL | 167 participants | 51 participants | 57 participants | 59 participants |
| Triglycerides, Categorical ≥500 mg/dL | 18 participants | 8 participants | 7 participants | 3 participants |
| Waist Circumference | 91.53 cm STANDARD_DEVIATION 9.161 | 91.51 cm STANDARD_DEVIATION 9.232 | 91.24 cm STANDARD_DEVIATION 9.376 | 91.85 cm STANDARD_DEVIATION 8.901 |
| Waist Circumference, Categorical Female <90.0 cm | 80 participants | 25 participants | 30 participants | 25 participants |
| Waist Circumference, Categorical Female ≥90.0 cm | 57 participants | 13 participants | 23 participants | 21 participants |
| Waist Circumference, Categorical Male <85.0 cm | 81 participants | 32 participants | 26 participants | 23 participants |
| Waist Circumference, Categorical Male ≥85.0 cm | 392 participants | 125 participants | 131 participants | 136 participants |
| Weight | 72.71 kg STANDARD_DEVIATION 12.962 | 72.90 kg STANDARD_DEVIATION 13.375 | 72.20 kg STANDARD_DEVIATION 12.435 | 73.04 kg STANDARD_DEVIATION 13.139 |
| Weight, Categorical ≥60.0 - <70.0 kg | 177 participants | 58 participants | 61 participants | 58 participants |
| Weight, Categorical <60.0 kg | 99 participants | 33 participants | 33 participants | 33 participants |
| Weight, Categorical ≥70.0 - <80.0 kg | 173 participants | 49 participants | 68 participants | 56 participants |
| Weight, Categorical ≥80.0 kg | 161 participants | 55 participants | 48 participants | 58 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 205 | 9 / 210 | 20 / 195 |
| serious Total, serious adverse events | 1 / 205 | 4 / 210 | 2 / 195 |
Outcome results
Primary
Percent Change From Baseline in Triglyceride Level at the Final Visit
The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.
Time frame: Baseline and 12 weeks
Population: Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Triglyceride Level at the Final Visit | -10.93 percent change | Standard Error 1.6434 |
| TAK-085 4 g | Percent Change From Baseline in Triglyceride Level at the Final Visit | -22.65 percent change | Standard Error 1.6238 |
| EPA-E 1.8 g | Percent Change From Baseline in Triglyceride Level at the Final Visit | -11.30 percent change | Standard Error 1.6807 |
p-value: 0.87695% CI: [-4.2491, 4.983]ANCOVA
p-value: <0.000195% CI: [-15.9442, -6.7637]ANCOVA
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration
Time frame: 12 Weeks
Population: Safety Analysis Set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-085 2 g | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration | 0 participants |
| TAK-085 4 g | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration | 0 participants |
| EPA-E 1.8 g | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration | 0 participants |
Secondary
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Time frame: 12 Weeks
Population: Safety Analysis Set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| TAK-085 2 g | Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | 1 participants | 10.81 |
| TAK-085 4 g | Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | 0 participants | 10.61 |
| EPA-E 1.8 g | Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | 0 participants | 10.92 |
Secondary
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame: 12 Weeks
Population: Safety Analysis Set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-085 2 g | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 11 participants |
| TAK-085 4 g | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 11 participants |
| EPA-E 1.8 g | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 7 participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 Weeks
Population: Safety Analysis Set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-085 2 g | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 88 participants |
| TAK-085 4 g | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 76 participants |
| EPA-E 1.8 g | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 83 participants |
Secondary
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time
The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Population: Full analysis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 4 (n=203, 208, 194) | 2.990 percent change | Standard Deviation 10.5365 |
| TAK-085 2 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 8 (n=200, 205, 191) | 1.547 percent change | Standard Deviation 11.6333 |
| TAK-085 2 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 10 (n=199, 202, 188) | 2.258 percent change | Standard Deviation 10.6907 |
| TAK-085 2 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 12 (n=199, 200, 187) | 2.685 percent change | Standard Deviation 10.8647 |
| TAK-085 4 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 12 (n=199, 200, 187) | 4.564 percent change | Standard Deviation 12.7497 |
| TAK-085 4 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 4 (n=203, 208, 194) | 4.075 percent change | Standard Deviation 10.9735 |
| TAK-085 4 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 10 (n=199, 202, 188) | 4.219 percent change | Standard Deviation 12.0895 |
| TAK-085 4 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 8 (n=200, 205, 191) | 3.936 percent change | Standard Deviation 12.4198 |
| EPA-E 1.8 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 12 (n=199, 200, 187) | 1.741 percent change | Standard Deviation 10.8185 |
| EPA-E 1.8 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 8 (n=200, 205, 191) | 1.826 percent change | Standard Deviation 10.1747 |
| EPA-E 1.8 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 10 (n=199, 202, 188) | 1.860 percent change | Standard Deviation 11.0573 |
| EPA-E 1.8 g | Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time | Week 4 (n=203, 208, 194) | 0.934 percent change | Standard Deviation 11.6203 |
Secondary
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time
The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Population: Full analysis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 4 (n=203, 208, 194) | 1.120 percent change | Standard Deviation 16.0172 |
| TAK-085 2 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 8 (n=200, 205, 191) | -0.846 percent change | Standard Deviation 15.5473 |
| TAK-085 2 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 10 (n=199, 202, 188) | -3.055 percent change | Standard Deviation 15.6128 |
| TAK-085 2 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 12 (n=199, 200, 187) | -1.639 percent change | Standard Deviation 16.3582 |
| TAK-085 4 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 12 (n=199, 200, 187) | -1.056 percent change | Standard Deviation 18.2732 |
| TAK-085 4 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 4 (n=203, 208, 194) | 2.262 percent change | Standard Deviation 15.5408 |
| TAK-085 4 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 10 (n=199, 202, 188) | -0.862 percent change | Standard Deviation 18.031 |
| TAK-085 4 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 8 (n=200, 205, 191) | -0.420 percent change | Standard Deviation 17.7696 |
| EPA-E 1.8 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 12 (n=199, 200, 187) | -3.393 percent change | Standard Deviation 17.2972 |
| EPA-E 1.8 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 8 (n=200, 205, 191) | -3.008 percent change | Standard Deviation 13.8462 |
| EPA-E 1.8 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 10 (n=199, 202, 188) | -4.297 percent change | Standard Deviation 14.0827 |
| EPA-E 1.8 g | Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time | Week 4 (n=203, 208, 194) | -3.409 percent change | Standard Deviation 13.5003 |
Secondary
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time
The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Population: Full analysis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 4 (n=203, 208, 194) | -1.955 percent change | Standard Deviation 12.7395 |
| TAK-085 2 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 8 (n=200, 205, 191) | -3.022 percent change | Standard Deviation 11.2524 |
| TAK-085 2 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 10 (n=199, 202, 188) | -4.624 percent change | Standard Deviation 11.2058 |
| TAK-085 2 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 12 (n=199, 200, 187) | -4.159 percent change | Standard Deviation 11.5205 |
| TAK-085 4 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 12 (n=199, 200, 187) | -5.384 percent change | Standard Deviation 13.2602 |
| TAK-085 4 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 4 (n=203, 208, 194) | -4.634 percent change | Standard Deviation 11.3386 |
| TAK-085 4 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 10 (n=199, 202, 188) | -6.190 percent change | Standard Deviation 12.9755 |
| TAK-085 4 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 8 (n=200, 205, 191) | -4.931 percent change | Standard Deviation 11.9003 |
| EPA-E 1.8 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 12 (n=199, 200, 187) | -5.140 percent change | Standard Deviation 14.3444 |
| EPA-E 1.8 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 8 (n=200, 205, 191) | -4.418 percent change | Standard Deviation 11.5415 |
| EPA-E 1.8 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 10 (n=199, 202, 188) | -5.994 percent change | Standard Deviation 11.1866 |
| EPA-E 1.8 g | Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time | Week 4 (n=203, 208, 194) | -4.274 percent change | Standard Deviation 10.8403 |
Secondary
Percent Change From Baseline in Total Cholesterol Over Time
The percentage change between total cholesterol measured at each study visit relative to Baseline.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Population: Full analysis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 4 (n=203, 208, 194) | -0.841 percent change | Standard Deviation 10.0601 |
| TAK-085 2 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 8 (n=200, 205, 191) | -1.996 percent change | Standard Deviation 9.519 |
| TAK-085 2 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 10 (n=199, 202, 188) | -3.054 percent change | Standard Deviation 9.0927 |
| TAK-085 2 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 12 (n=199, 200, 187) | -2.649 percent change | Standard Deviation 9.4133 |
| TAK-085 4 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 12 (n=199, 200, 187) | -3.243 percent change | Standard Deviation 10.6025 |
| TAK-085 4 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 4 (n=203, 208, 194) | -2.707 percent change | Standard Deviation 9.0969 |
| TAK-085 4 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 10 (n=199, 202, 188) | -3.949 percent change | Standard Deviation 10.5345 |
| TAK-085 4 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 8 (n=200, 205, 191) | -2.887 percent change | Standard Deviation 9.7964 |
| EPA-E 1.8 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 12 (n=199, 200, 187) | -3.880 percent change | Standard Deviation 10.8594 |
| EPA-E 1.8 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 8 (n=200, 205, 191) | -3.097 percent change | Standard Deviation 9.277 |
| EPA-E 1.8 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 10 (n=199, 202, 188) | -4.355 percent change | Standard Deviation 9.142 |
| EPA-E 1.8 g | Percent Change From Baseline in Total Cholesterol Over Time | Week 4 (n=203, 208, 194) | -3.152 percent change | Standard Deviation 8.1026 |
Secondary
Percent Change From Baseline in Triglyceride Level Over Time
The percentage change between triglycerides collected at each study visit relative to Baseline.
Time frame: Baseline and Weeks 4, 8, 10 and 12
Population: Full analysis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 10 (n=198, 202, 188) | -9.707 percent change | Standard Deviation 25.9148 |
| TAK-085 2 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 4 (n=203, 208, 192) | -13.085 percent change | Standard Deviation 26.4479 |
| TAK-085 2 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 12 (n=198, 199, 185) | -11.707 percent change | Standard Deviation 27.6764 |
| TAK-085 2 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 8 (n=199, 205, 191) | -12.055 percent change | Standard Deviation 23.5955 |
| TAK-085 4 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 10 (n=198, 202, 188) | -23.436 percent change | Standard Deviation 31.7008 |
| TAK-085 4 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 8 (n=199, 205, 191) | -22.501 percent change | Standard Deviation 29.7039 |
| TAK-085 4 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 4 (n=203, 208, 192) | -26.939 percent change | Standard Deviation 20.954 |
| TAK-085 4 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 12 (n=198, 199, 185) | -22.606 percent change | Standard Deviation 25.1665 |
| EPA-E 1.8 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 8 (n=199, 205, 191) | -11.321 percent change | Standard Deviation 29.6792 |
| EPA-E 1.8 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 4 (n=203, 208, 192) | -11.417 percent change | Standard Deviation 27.8599 |
| EPA-E 1.8 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 12 (n=198, 199, 185) | -12.431 percent change | Standard Deviation 31.0903 |
| EPA-E 1.8 g | Percent Change From Baseline in Triglyceride Level Over Time | Week 10 (n=198, 202, 188) | -11.416 percent change | Standard Deviation 28.4762 |