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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1185-0054 | Other Identifier | WHO | |
| JapicCTI-163322 | Registry Identifier | JapicCTI |
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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 esters.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Experimental | Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-085 | Drug | Omega-3-acid ethyl esters (TAK-085) capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Week 4, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4 and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noda | Chiba | Japan | ||||
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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Participants with a historical diagnosis of hyperlipidemia who were inadequately controlled while receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor were enrolled in one of two groups, treatment group with omega-3-acid ethyl esters (TAK-085) 2 grams (g) and treatment group without TAK-085 (Control Group).
Participants took part in the study at 7 investigative sites in Japan, from 27 December 2016 to 30 August 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-085 4 g | A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice 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. |
| FG001 | Control Group | Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-085 4 g | A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice 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. |
| BG001 |
| 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 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
Up to Week 8
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 4 g | A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2016 | Aug 28, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2017 | Aug 28, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C587319 | TAK-085 |
| C405603 | Omacor |
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| Not treated with omega-3-acid ethyl esters |
| Other |
Not treated with omega-3-acid ethyl esters |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Baseline, Week 4 and Week 8 |
| Koga |
| Ibaragi |
| Japan |
| Moriguchi | Osaka | Japan |
| Suita | Osaka | Japan |
| Fujimi | Saitama | Japan |
| Mitaka | Tokyo | Japan |
| Saitama | Japan |
| Control Group |
Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Height | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | Mean | Standard Deviation | Kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
|
| Duration of Hyperlipemia | Mean duration between start of study and first time of diagnosis of hyperlipemia was reported. | Mean | Standard Deviation | Years |
|
| Frequency of Fish Intake | Participants were asked a question about frequency of consumption of fish and answered from 4 types of the answers; Almost Every Day, About Every 2 Days, About Once or Twice per Week, and Rarely. Reported data were the number of participants who selected from 4 answers. | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Drinking habit | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
|
| Fasting Triglycerides | Mean | Standard Deviation | Milligram (mg)/deciliter (dL) |
|
| Cholesterol Concentration in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Mean | Standard Deviation | mg/dL |
|
| Triglycerides Concentration in sdLDL Fraction | Mean | Standard Deviation | mg/dL |
|
| Free Cholesterol Concentration in sdLDL Fraction | Mean | Standard Deviation | mg/dL |
|
| Phospholipid Concentration in sdLDL Fraction | Mean | Standard Deviation | mg/dL |
|
| Particle Size of LDL(Cholesterol Monitor) | Mean | Standard Deviation | Nanometer (nm) |
|
| Particle Size of LDL (Triglycerides Monitor) | Population Analysis Description: The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | nm |
|
| Particle Size of LDL (Free Cholesterol Monitor) | Mean | Standard Deviation | nm |
|
| Particle Size of LDL (Phospholipid Monitor) | Mean | Standard Deviation | nm |
|
| OG001 | Control Group | Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. |
|
|
|
| Primary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4, and Week 8 |
|
|
|
|
| Primary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4, and Week 8 |
|
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | 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. | Posted | Baseline, Week 4 and Week 8 |
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | 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). | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Percent of Change | Baseline, Week 4 and Week 8 |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Control Group | Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. | 0 | 29 | 0 | 29 | 0 | 29 |
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| About Once or Twice Per Week |
|
| Rarely |
|
| Ex-smoker |
|
| Week 8 (Cholesterol Monitor) |
|
|
| Week 4 (Triglycerides Monitor) |
|
|
| Week 8 (Triglycerides Monitor) |
|
|
| Week 4 (Free Cholesterol Monitor) |
|
|
| Week 8 (Free Cholesterol Monitor) |
|
|
| Week 4 (Phospholipid Monitor) |
|
|
| Week 8 (Phospholipid Monitor) |
|
|
The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model. |
| ANCOVA |
| 0.4428 |
| Least square (LS) mean difference |
| 1.553 |
| 2-Sided |
| 95 |
| -2.884 |
| 5.991 |
TAK-085 4 g - Control Group |
| Other |
Least square (LS) mean difference |
| The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model. | ANCOVA | 0.0570 | Least square (LS) mean difference | 0.760 | 2-Sided | 95 | -0.024 | 1.544 | TAK-085 4 g - Control Group | Other | Least square (LS) mean difference |
| The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model. | ANCOVA | 0.0360 | Least square (LS) mean difference | 0.838 | 2-Sided | 95 | 0.057 | 1.620 | TAK-085 4 g - Control Group | Other | Least square (LS) mean difference |
| Triglycerides at Week 4 |
|
| Triglycerides at Week 8 |
|
| Free Cholesterol at Week 4 |
|
| Free Cholesterol at Week 8 |
|
| Phospholipid at Week 4 |
|
| Phospholipid at Week 8 |
|
| Triglycerides at Week 4 |
|
| Triglycerides at Week 8 |
|
| Free Cholesterol at Week 4 |
|
| Free Cholesterol at Week 8 |
|
| Phospholipid at Week 4 |
|
| Phospholipid at Week 8 |
|
| Triglycerides at Week 4 |
|
| Triglycerides at Week 8 |
|
| Free Cholesterol at Week 4 |
|
| Free Cholesterol at Week 8 |
|
| Phospholipid at Week 4 |
|
| Phospholipid at Week 8 |
|
| Triglycerides at Week 4 |
|
| Triglycerides at Week 8 |
|
| Free Cholesterol at Week 4 |
|
| Free Cholesterol at Week 8 |
|
| Phospholipid at Week 4 |
|
| Phospholipid at Week 8 |
|
| Myristic Acid at Week 4 |
|
| Myristic Acid at Week 8 |
|
| Myristoleic Acid at Week 4 |
|
| Myristoleic Acid at Week 8 |
|
| Palmitic Acid at Week 4 |
|
| Palmitic Acid at Week 8 |
|
| Palmitoleic Acid at Week 4 |
|
| Palmitoleic Acid at Week 8 |
|
| Stearic Acid at Week 4 |
|
| Stearic Acid at Week 8 |
|
| Oleic Acid at Week 4 |
|
| Oleic Acid at Week 8 |
|
| Linoleic Acid at Week 4 |
|
| Linoleic Acid at Week 8 |
|
| Gamma-linolenic Acid at Week 4 |
|
| Gamma-linolenic Acid at Week 8 |
|
| Linolenic Acid at Week 4 |
|
| Linolenic Acid at Week 8 |
|
| Arachic Acid at Week 4 |
|
| Arachic Acid at Week 8 |
|
| Eicosenoic Acid at Week 4 |
|
| Eicosenoic Acid at Week 8 |
|
| Eicosadienoic Acid at Week 4 |
|
| Eicosadienoic Acid at Week 8 |
|
| 5-8-11 Eicosatrienoic Acid at Week 4 |
|
| 5-8-11 Eicosatrienoic Acid at Week 8 |
|
| Dihomo-gamma-linolenic Acid at Week 4 |
|
| Dihomo-gamma-linolenic Acid at Week 8 |
|
| Arachidonic Acid at Week 4 |
|
| Arachidonic Acid at Week 8 |
|
| Eicosapentaenoic Acid at Week 4 |
|
| Eicosapentaenoic Acid at Week 8 |
|
| Behenic Acid at Week 4 |
|
| Behenic Acid at Week 8 |
|
| Erucic Acid at Week 4 |
|
| Erucic Acid at Week 8 |
|
| Docosatetraenoic Acid at Week 4 |
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| Docosatetraenoic Acid at Week 8 |
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| Docosapentaenoic Acid at Week 4 |
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| Docosapentaenoic Acid at Week 8 |
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| Lignoceric Acid at Week 4 |
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| Lignoceric Acid at Week 8 |
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| Docosahexaenoic Acid at Week 4 |
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| Docosahexaenoic Acid at Week 8 |
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| Nervonic Acid Week 4 |
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| Nervonic Acid Week 8 |
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| TG at Week 4 |
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| TG at Week 8 |
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| HDL-C (Direct) at Week 4 |
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| HDL-C (Direct) at Week 8 |
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| Non-HDL at Week 4 |
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| Non-HDL at Week 8 |
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| RemL-C at Week 4 |
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| RemL-C at Week 8 |
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| Apolipoprotein AII at Week 4 |
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| Apolipoprotein AII at Week 8 |
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| Apolipoprotein B at Week 4 |
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| Apolipoprotein B at Week 8 |
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| Apolipoprotein B-48 at Week 4 |
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| Apolipoprotein B-48 at Week 8 |
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| Apolipoprotein B-100 at Week 4 |
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| Apolipoprotein B-100 at Week 8 |
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| Apolipoprotein CII at Week 4 |
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| Apolipoprotein CII at Week 8 |
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| Apolipoprotein CIII at Week 4 |
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| Apolipoprotein CIII at Week 8 |
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| Apolipoprotein CII/III at Week 4 |
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| Apolipoprotein CII/III at Week 8 |
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| Apolipoprotein E at Week 4 |
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| Apolipoprotein E at Week 8 |
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| VLDL Fraction at Week 4 |
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| VLDL Fraction at Week 8 |
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| LDL Fraction at Week 4 |
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| LDL Fraction at Week 8 |
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| HDL Fraction at Week 4 |
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| HDL Fraction at Week 8 |
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