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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090937 | Registry Identifier | JapicCTI | |
| U1111-1120-7801 | Registry Identifier | WHO | |
| JapicCTI-R140452 | Registry Identifier | JapicCTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-085 2 g | Experimental | TAK-085 2 g, orally, once daily for up to 12 weeks. |
|
| TAK-085 4 g | Experimental | TAK-085 2 g, orally, twice daily for up to 12 weeks. |
|
| EPA-E 1.8 g | Experimental | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3-acid ethyl esters 90 (TAK-085) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Triglyceride Level Over Time | The percentage change between triglycerides collected at each study visit relative to Baseline. | Baseline and Weeks 4, 8, 10 and 12 |
| Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Associate Professor, Clinical Cell Biology and Medicine | Graduate School of Medicine, Chiba University | Study Director |
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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 took part in the study at 69 investigational sites in Japan from 21 November 2009 to 28 December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-085 2 g | TAK-085 2 g, orally, once daily for up to 12 weeks. |
| FG001 | TAK-085 4 g | TAK-085 2 g, orally, twice daily for up to 12 weeks. |
| FG002 | EPA-E 1.8 g | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-085 2 g | TAK-085 2 g, orally, once daily for up to 12 weeks. |
| BG001 | TAK-085 4 g | TAK-085 2 g, orally, twice daily for up to 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and 12 weeks |
|
Collection of AEs commenced from the time that the subject was first administered investigational product (Week 0). Routine collection of AEs continued until the completion of study treatment (12 weeks of administration)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-085 2 g | TAK-085 2 g, orally, once daily for up to 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C587319 | TAK-085 |
| C405603 | Omacor |
| C035276 | eicosapentaenoic acid ethyl ester |
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|
| Eicosapentaenoic acid-ethyl (EPA-E) | Drug | EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks. |
|
|
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. |
| Baseline and Weeks 4, 8, 10 and 12 |
| Percent Change From Baseline in Total Cholesterol Over Time | The percentage change between total cholesterol measured at each study visit relative to Baseline. | Baseline and Weeks 4, 8, 10 and 12 |
| 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. | Baseline and Weeks 4, 8, 10 and 12 |
| 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. | Baseline and Weeks 4, 8, 10 and 12 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 12 Weeks |
| 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 |
| BG002 | EPA-E 1.8 g | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Menopause Status | Number | participants |
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| Height, Categorical | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight, Categorical | The number of participants with available weight data are 205, 210 and 195 in each treatment arm, respectively. | Number | participants |
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| Weight | The number of participants with available weight data are 205, 210 and 195 in each treatment arm, respectively. | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI), Categorical | The number of participants with available BMI data are 205, 210 and 195 in each treatment arm, respectively. | Number | participants |
|
| Body Mass Index | The number of participants with available BMI data are 205, 210 and 195 in each treatment arm, respectively. | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Classification | Number | participants |
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| Waist Circumference, Categorical | The number of participants with available waist circumference data are 205, 210 and 195 in each treatment arm, respectively. Mean | Number | participants |
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| Waist Circumference | The number of participants with available waist circumference data are 205, 210 and 195 in each treatment arm, respectively. | Mean | Standard Deviation | cm |
|
| Coronary Artery Disease (CAD) Category | CAD Patient Categories define the degree of risk of CAD according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. Categories are classified by the degree of risks in the patient [e.g, smoking, hypertension, excluding level of low density lipoprotein cholesterol (LDL-C)]. Category I=Low risk (best), Category II=Middle risk, Category III=High Risk and History of CAD. | Number | participants |
|
| Hypertension | Number | participants |
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| Diabetes Mellitus (Including Impaired Glucose Tolerance) | Number | participants |
|
| Low High Density Lipoprotein - Cholesterol (HDL-C) | Number | participants |
|
| Administration of 3-hydroxy 3-methylglutaryl coenzyme A (HMGCoA) Reductase Inhibitor | Number | participants |
|
| Triglycerides, Categorical | The number of participants with available triglyceride data are 205, 210 and 195 in each treatment arm, respectively. | Number | participants |
|
| Triglycerides | The number of participants with available triglyceride data are 205, 210 and 195 in each treatment arm, respectively. | Mean | Standard Deviation | mg/dL |
|
| Low Density Lipoprotein - Cholesterol (LDL-C), Categorical | The number of participants with available LDL-C data are 205, 210 and 195 in each treatment arm, respectively. | Number | participants |
|
| Low Density Lipoprotein - Cholesterol (LDL-C) | The number of participants with available LDL-C data are 205, 210 and 195 in each treatment arm, respectively. | Mean | Standard Deviation | mg/dL |
|
TAK-085 2 g, orally, twice daily for up to 12 weeks. |
| OG002 | EPA-E 1.8 g | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. |
|
|
|
| Secondary | Percent Change From Baseline in Triglyceride Level Over Time | The percentage change between triglycerides collected at each study visit relative to Baseline. | Full analysis set with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 4, 8, 10 and 12 |
|
|
|
| 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. | Full analysis set with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 4, 8, 10 and 12 |
|
|
|
| Secondary | Percent Change From Baseline in Total Cholesterol Over Time | The percentage change between total cholesterol measured at each study visit relative to Baseline. | Full analysis set with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 4, 8, 10 and 12 |
|
|
|
| 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. | Full analysis set with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 4, 8, 10 and 12 |
|
|
|
| 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. | Full analysis set with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 4, 8, 10 and 12 |
|
|
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Safety Analysis Set included all participants who received at least one dose of the investigational product. | Posted | Number | participants | 12 Weeks |
|
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| Secondary | Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs | Safety Analysis Set included all participants who received at least one dose of the investigational product. | Posted | Number | participants | 12 Weeks |
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| Secondary | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Safety Analysis Set included all participants who received at least one dose of the investigational product. | Posted | Number | participants | 12 Weeks |
|
|
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| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration | Safety Analysis Set included all participants who received at least one dose of the investigational product. | Posted | Number | participants | 12 Weeks |
|
|
|
| 1 |
| 205 |
| 22 |
| 205 |
| EG001 | TAK-085 4 g | TAK-085 2 g, orally, twice daily for up to 12 weeks. | 4 | 210 | 9 | 210 |
| EG002 | EPA-E 1.8 g | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. | 2 | 195 | 20 | 195 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
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| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 13.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
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| VIIth nerve paralysis | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA version 13.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
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The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
| D009750 |
| Nutritional and Metabolic Diseases |
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| Week 10 (n=198, 202, 188) |
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| Week 12 (n=198, 199, 185) |
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| Week 10 (n=199, 202, 188) |
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| Week 12 (n=199, 200, 187) |
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| Week 10 (n=199, 202, 188) |
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| Week 12 (n=199, 200, 187) |
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| Week 10 (n=199, 202, 188) |
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| Week 12 (n=199, 200, 187) |
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| Week 10 (n=199, 202, 188) |
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| Week 12 (n=199, 200, 187) |
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