Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02839902
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587319', 'term': 'TAK-085'}, {'id': 'C405603', 'term': 'Omacor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 8', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'TAK-085 4 g', 'description': '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.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-6.50', 'spread': '15.745', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '11.401', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-12.35', 'spread': '13.519', 'groupId': 'OG000'}, {'value': '4.64', 'spread': '17.845', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 4', 'categories': [{'measurements': [{'value': '-2.87', 'spread': '22.917', 'groupId': 'OG000'}, {'value': '9.71', 'spread': '23.437', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 8', 'categories': [{'measurements': [{'value': '-6.50', 'spread': '22.615', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '20.317', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-6.32', 'spread': '12.483', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '14.048', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-6.94', 'spread': '16.639', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '14.516', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 4', 'categories': [{'measurements': [{'value': '-8.31', 'spread': '11.396', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '11.297', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 8', 'categories': [{'measurements': [{'value': '-10.37', 'spread': '13.919', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '13.440', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.147', 'ciLowerLimit': '-26.344', 'ciUpperLimit': '-7.950', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': 'The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}, {'pValue': '0.1141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.774', 'ciLowerLimit': '-21.986', 'ciUpperLimit': '2.439', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': 'The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}, {'pValue': '0.0248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.246', 'ciLowerLimit': '-19.143', 'ciUpperLimit': '-1.349', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': 'The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}, {'pValue': '0.0047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.511', 'ciLowerLimit': '-19.340', 'ciUpperLimit': '-3.682', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': 'The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': 'Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.48', 'spread': '21.423', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '25.908', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '8.64', 'spread': '31.398', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '17.267', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.499', 'ciLowerLimit': '-4.623', 'ciUpperLimit': '23.622', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': 'The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, and Week 8', 'description': 'Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Week 4 (Cholesterol Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '1.217', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.820', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (Cholesterol Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '1.192', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '1.274', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Triglycerides Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '6.026', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '1.367', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (Triglycerides Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.11', 'spread': '2.715', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '3.155', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Free Cholesterol Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.247', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.953', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (Free Cholesterol Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '1.407', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.361', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Phospholipid Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.464', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '1.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (Phospholipid Monitor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '1.316', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.431', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.066', 'ciLowerLimit': '0.356', 'ciUpperLimit': '1.776', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': 'The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}, {'pValue': '0.4428', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.553', 'ciLowerLimit': '-2.884', 'ciUpperLimit': '5.991', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': '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.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}, {'pValue': '0.0570', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.760', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '1.544', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': '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.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}, {'pValue': '0.0360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.838', 'ciLowerLimit': '0.057', 'ciUpperLimit': '1.620', 'estimateComment': 'TAK-085 4 g - Control Group', 'groupDescription': '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.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Least square (LS) mean difference'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-38.03', 'spread': '53.008', 'groupId': 'OG000'}, {'value': '47.42', 'spread': '149.946', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-32.92', 'spread': '60.170', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '65.088', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 4', 'categories': [{'measurements': [{'value': '-37.22', 'spread': '49.604', 'groupId': 'OG000'}, {'value': '42.62', 'spread': '132.804', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 8', 'categories': [{'measurements': [{'value': '-33.32', 'spread': '52.994', 'groupId': 'OG000'}, {'value': '-3.74', 'spread': '55.812', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-38.13', 'spread': '50.570', 'groupId': 'OG000'}, {'value': '60.20', 'spread': '189.062', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-30.33', 'spread': '65.974', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '71.895', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 4', 'categories': [{'measurements': [{'value': '-40.25', 'spread': '61.678', 'groupId': 'OG000'}, {'value': '48.94', 'spread': '118.843', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 8', 'categories': [{'measurements': [{'value': '-38.00', 'spread': '64.130', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '92.004', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-10.45', 'spread': '17.089', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '15.255', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-15.16', 'spread': '19.449', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '14.717', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 4', 'categories': [{'measurements': [{'value': '-15.21', 'spread': '23.536', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '28.285', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 8', 'categories': [{'measurements': [{'value': '-17.26', 'spread': '24.705', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '20.084', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-13.06', 'spread': '19.539', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '20.379', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-16.48', 'spread': '24.694', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '17.034', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 4', 'categories': [{'measurements': [{'value': '-13.78', 'spread': '19.839', 'groupId': 'OG000'}, {'value': '5.99', 'spread': '19.193', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 8', 'categories': [{'measurements': [{'value': '-16.49', 'spread': '22.717', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '16.446', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-4.40', 'spread': '10.300', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '11.146', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-6.25', 'spread': '12.087', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '11.789', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 4', 'categories': [{'measurements': [{'value': '0.38', 'spread': '13.307', 'groupId': 'OG000'}, {'value': '3.82', 'spread': '10.813', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 8', 'categories': [{'measurements': [{'value': '-2.28', 'spread': '15.034', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '12.348', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '12.581', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '13.908', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '15.395', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '12.404', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 4', 'categories': [{'measurements': [{'value': '-3.94', 'spread': '8.257', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '9.809', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 8', 'categories': [{'measurements': [{'value': '-4.80', 'spread': '10.561', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '9.817', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-1.49', 'spread': '7.316', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '8.039', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-3.24', 'spread': '9.567', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '8.249', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 4', 'categories': [{'measurements': [{'value': '-9.07', 'spread': '23.323', 'groupId': 'OG000'}, {'value': '6.20', 'spread': '23.726', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides at Week 8', 'categories': [{'measurements': [{'value': '-6.99', 'spread': '34.397', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '19.979', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-2.56', 'spread': '9.832', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '9.708', 'groupId': 'OG001'}]}]}, {'title': 'Free Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-3.31', 'spread': '12.969', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '12.174', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 4', 'categories': [{'measurements': [{'value': '-6.47', 'spread': '7.169', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '8.029', 'groupId': 'OG001'}]}]}, {'title': 'Phospholipid at Week 8', 'categories': [{'measurements': [{'value': '-6.45', 'spread': '10.432', 'groupId': 'OG000'}, {'value': '-3.40', 'spread': '10.212', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Lauric Acid at Week 4', 'categories': [{'measurements': [{'value': '-13.26', 'spread': '56.101', 'groupId': 'OG000'}, {'value': '50.65', 'spread': '86.467', 'groupId': 'OG001'}]}]}, {'title': 'Lauric Acid at Week 8', 'categories': [{'measurements': [{'value': '6.84', 'spread': '85.494', 'groupId': 'OG000'}, {'value': '34.60', 'spread': '138.684', 'groupId': 'OG001'}]}]}, {'title': 'Myristic Acid at Week 4', 'categories': [{'measurements': [{'value': '-21.37', 'spread': '26.046', 'groupId': 'OG000'}, {'value': '24.68', 'spread': '54.142', 'groupId': 'OG001'}]}]}, {'title': 'Myristic Acid at Week 8', 'categories': [{'measurements': [{'value': '-13.31', 'spread': '33.571', 'groupId': 'OG000'}, {'value': '5.96', 'spread': '32.534', 'groupId': 'OG001'}]}]}, {'title': 'Myristoleic Acid at Week 4', 'categories': [{'measurements': [{'value': '-31.40', 'spread': '25.830', 'groupId': 'OG000'}, {'value': '32.50', 'spread': '77.309', 'groupId': 'OG001'}]}]}, {'title': 'Myristoleic Acid at Week 8', 'categories': [{'measurements': [{'value': '-8.54', 'spread': '100.145', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '37.180', 'groupId': 'OG001'}]}]}, {'title': 'Palmitic Acid at Week 4', 'categories': [{'measurements': [{'value': '-12.49', 'spread': '20.682', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '17.277', 'groupId': 'OG001'}]}]}, {'title': 'Palmitic Acid at Week 8', 'categories': [{'measurements': [{'value': '-9.62', 'spread': '22.355', 'groupId': 'OG000'}, {'value': '-2.63', 'spread': '15.549', 'groupId': 'OG001'}]}]}, {'title': 'Palmitoleic Acid at Week 4', 'categories': [{'measurements': [{'value': '-22.35', 'spread': '22.371', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '29.987', 'groupId': 'OG001'}]}]}, {'title': 'Palmitoleic Acid at Week 8', 'categories': [{'measurements': [{'value': '-19.25', 'spread': '27.584', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '22.775', 'groupId': 'OG001'}]}]}, {'title': 'Stearic Acid at Week 4', 'categories': [{'measurements': [{'value': '-4.74', 'spread': '22.322', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '16.408', 'groupId': 'OG001'}]}]}, {'title': 'Stearic Acid at Week 8', 'categories': [{'measurements': [{'value': '-3.17', 'spread': '24.102', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '14.957', 'groupId': 'OG001'}]}]}, {'title': 'Oleic Acid at Week 4', 'categories': [{'measurements': [{'value': '-17.77', 'spread': '23.295', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '19.641', 'groupId': 'OG001'}]}]}, {'title': 'Oleic Acid at Week 8', 'categories': [{'measurements': [{'value': '-13.77', 'spread': '25.958', 'groupId': 'OG000'}, {'value': '-4.90', 'spread': '15.856', 'groupId': 'OG001'}]}]}, {'title': 'Linoleic Acid at Week 4', 'categories': [{'measurements': [{'value': '-10.47', 'spread': '17.286', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '12.616', 'groupId': 'OG001'}]}]}, {'title': 'Linoleic Acid at Week 8', 'categories': [{'measurements': [{'value': '-11.84', 'spread': '16.303', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '14.748', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-linolenic Acid at Week 4', 'categories': [{'measurements': [{'value': '-34.84', 'spread': '17.846', 'groupId': 'OG000'}, {'value': '7.82', 'spread': '35.906', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-linolenic Acid at Week 8', 'categories': [{'measurements': [{'value': '-35.21', 'spread': '19.170', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '23.426', 'groupId': 'OG001'}]}]}, {'title': 'Linolenic Acid at Week 4', 'categories': [{'measurements': [{'value': '-9.50', 'spread': '26.598', 'groupId': 'OG000'}, {'value': '12.09', 'spread': '34.208', 'groupId': 'OG001'}]}]}, {'title': 'Linolenic Acid at Week 8', 'categories': [{'measurements': [{'value': '-7.27', 'spread': '30.301', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '25.026', 'groupId': 'OG001'}]}]}, {'title': 'Arachic Acid at Week 4', 'categories': [{'measurements': [{'value': '-15.59', 'spread': '32.158', 'groupId': 'OG000'}, {'value': '8.20', 'spread': '35.594', 'groupId': 'OG001'}]}]}, {'title': 'Arachic Acid at Week 8', 'categories': [{'measurements': [{'value': '-7.11', 'spread': '43.510', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '32.969', 'groupId': 'OG001'}]}]}, {'title': 'Eicosenoic Acid at Week 4', 'categories': [{'measurements': [{'value': '-22.66', 'spread': '30.315', 'groupId': 'OG000'}, {'value': '6.82', 'spread': '41.150', 'groupId': 'OG001'}]}]}, {'title': 'Eicosenoic Acid at Week 8', 'categories': [{'measurements': [{'value': '-19.43', 'spread': '28.872', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '27.505', 'groupId': 'OG001'}]}]}, {'title': 'Eicosadienoic Acid at Week 4', 'categories': [{'measurements': [{'value': '-23.82', 'spread': '18.803', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '14.078', 'groupId': 'OG001'}]}]}, {'title': 'Eicosadienoic Acid at Week 8', 'categories': [{'measurements': [{'value': '-21.50', 'spread': '21.967', 'groupId': 'OG000'}, {'value': '-3.17', 'spread': '18.978', 'groupId': 'OG001'}]}]}, {'title': '5-8-11 Eicosatrienoic Acid at Week 4', 'categories': [{'measurements': [{'value': '-42.51', 'spread': '23.478', 'groupId': 'OG000'}, {'value': '17.71', 'spread': '68.061', 'groupId': 'OG001'}]}]}, {'title': '5-8-11 Eicosatrienoic Acid at Week 8', 'categories': [{'measurements': [{'value': '-48.16', 'spread': '24.514', 'groupId': 'OG000'}, {'value': '13.24', 'spread': '38.481', 'groupId': 'OG001'}]}]}, {'title': 'Dihomo-gamma-linolenic Acid at Week 4', 'categories': [{'measurements': [{'value': '-38.14', 'spread': '15.452', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '17.847', 'groupId': 'OG001'}]}]}, {'title': 'Dihomo-gamma-linolenic Acid at Week 8', 'categories': [{'measurements': [{'value': '-37.18', 'spread': '15.933', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '22.295', 'groupId': 'OG001'}]}]}, {'title': 'Arachidonic Acid at Week 4', 'categories': [{'measurements': [{'value': '-16.23', 'spread': '11.911', 'groupId': 'OG000'}, {'value': '-1.97', 'spread': '13.223', 'groupId': 'OG001'}]}]}, {'title': 'Arachidonic Acid at Week 8', 'categories': [{'measurements': [{'value': '-18.35', 'spread': '14.448', 'groupId': 'OG000'}, {'value': '-2.37', 'spread': '13.220', 'groupId': 'OG001'}]}]}, {'title': 'Eicosapentaenoic Acid at Week 4', 'categories': [{'measurements': [{'value': '224.30', 'spread': '155.842', 'groupId': 'OG000'}, {'value': '16.58', 'spread': '53.986', 'groupId': 'OG001'}]}]}, {'title': 'Eicosapentaenoic Acid at Week 8', 'categories': [{'measurements': [{'value': '238.48', 'spread': '211.242', 'groupId': 'OG000'}, {'value': '29.05', 'spread': '83.267', 'groupId': 'OG001'}]}]}, {'title': 'Behenic Acid at Week 4', 'categories': [{'measurements': [{'value': '-3.33', 'spread': '47.184', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '36.672', 'groupId': 'OG001'}]}]}, {'title': 'Behenic Acid at Week 8', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '48.418', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '39.343', 'groupId': 'OG001'}]}]}, {'title': 'Erucic Acid at Week 4', 'categories': [{'measurements': [{'value': '27.58', 'spread': '279.981', 'groupId': 'OG000'}, {'value': '91.40', 'spread': '214.836', 'groupId': 'OG001'}]}]}, {'title': 'Erucic Acid at Week 8', 'categories': [{'measurements': [{'value': '-18.05', 'spread': '71.360', 'groupId': 'OG000'}, {'value': '139.93', 'spread': '376.748', 'groupId': 'OG001'}]}]}, {'title': 'Docosatetraenoic Acid at Week 4', 'categories': [{'measurements': [{'value': '-36.43', 'spread': '17.765', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '23.847', 'groupId': 'OG001'}]}]}, {'title': 'Docosatetraenoic Acid at Week 8', 'categories': [{'measurements': [{'value': '-37.74', 'spread': '17.764', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '21.927', 'groupId': 'OG001'}]}]}, {'title': 'Docosapentaenoic Acid at Week 4', 'categories': [{'measurements': [{'value': '18.16', 'spread': '27.789', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '22.423', 'groupId': 'OG001'}]}]}, {'title': 'Docosapentaenoic Acid at Week 8', 'categories': [{'measurements': [{'value': '19.89', 'spread': '33.735', 'groupId': 'OG000'}, {'value': '5.78', 'spread': '25.442', 'groupId': 'OG001'}]}]}, {'title': 'Lignoceric Acid at Week 4', 'categories': [{'measurements': [{'value': '-9.06', 'spread': '20.062', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '20.004', 'groupId': 'OG001'}]}]}, {'title': 'Lignoceric Acid at Week 8', 'categories': [{'measurements': [{'value': '-5.01', 'spread': '25.548', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '24.698', 'groupId': 'OG001'}]}]}, {'title': 'Docosahexaenoic Acid at Week 4', 'categories': [{'measurements': [{'value': '30.71', 'spread': '25.367', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '20.643', 'groupId': 'OG001'}]}]}, {'title': 'Docosahexaenoic Acid at Week 8', 'categories': [{'measurements': [{'value': '34.00', 'spread': '41.055', 'groupId': 'OG000'}, {'value': '7.32', 'spread': '27.833', 'groupId': 'OG001'}]}]}, {'title': 'Nervonic Acid Week 4', 'categories': [{'measurements': [{'value': '-8.61', 'spread': '14.334', 'groupId': 'OG000'}, {'value': '5.98', 'spread': '25.020', 'groupId': 'OG001'}]}]}, {'title': 'Nervonic Acid Week 8', 'categories': [{'measurements': [{'value': '-7.82', 'spread': '15.480', 'groupId': 'OG000'}, {'value': '13.04', 'spread': '29.043', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-11.81', 'spread': '23.814', 'groupId': 'OG000'}, {'value': '8.62', 'spread': '35.529', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-12.50', 'spread': '22.656', 'groupId': 'OG000'}, {'value': '12.07', 'spread': '43.620', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '293.83', 'spread': '185.305', 'groupId': 'OG000'}, {'value': '18.98', 'spread': '47.676', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '317.31', 'spread': '212.306', 'groupId': 'OG000'}, {'value': '31.77', 'spread': '75.839', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '118.68', 'spread': '57.033', 'groupId': 'OG000'}, {'value': '8.87', 'spread': '28.154', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '132.20', 'spread': '76.024', 'groupId': 'OG000'}, {'value': '14.29', 'spread': '34.060', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '57.80', 'spread': '31.135', 'groupId': 'OG000'}, {'value': '6.22', 'spread': '22.634', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '66.11', 'spread': '43.927', 'groupId': 'OG000'}, {'value': '10.29', 'spread': '25.525', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Concentration of Lipids in the Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Total Cholesterol at Week 4', 'categories': [{'measurements': [{'value': '-5.74', 'spread': '7.680', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '8.336', 'groupId': 'OG001'}]}]}, {'title': 'Total Cholesterol at Week 8', 'categories': [{'measurements': [{'value': '-7.07', 'spread': '8.325', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '8.267', 'groupId': 'OG001'}]}]}, {'title': 'TG at Week 4', 'categories': [{'measurements': [{'value': '-16.57', 'spread': '27.101', 'groupId': 'OG000'}, {'value': '9.60', 'spread': '34.407', 'groupId': 'OG001'}]}]}, {'title': 'TG at Week 8', 'categories': [{'measurements': [{'value': '-14.51', 'spread': '32.860', 'groupId': 'OG000'}, {'value': '-2.49', 'spread': '22.313', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C (Direct) at Week 4', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '8.290', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '9.386', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C (Direct) at Week 8', 'categories': [{'measurements': [{'value': '-1.42', 'spread': '10.575', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '8.305', 'groupId': 'OG001'}]}]}, {'title': 'Non-HDL at Week 4', 'categories': [{'measurements': [{'value': '-7.71', 'spread': '10.152', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '9.978', 'groupId': 'OG001'}]}]}, {'title': 'Non-HDL at Week 8', 'categories': [{'measurements': [{'value': '-9.30', 'spread': '11.473', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '10.898', 'groupId': 'OG001'}]}]}, {'title': 'RemL-C at Week 4', 'categories': [{'measurements': [{'value': '-26.62', 'spread': '29.222', 'groupId': 'OG000'}, {'value': '15.84', 'spread': '47.272', 'groupId': 'OG001'}]}]}, {'title': 'RemL-C at Week 8', 'categories': [{'measurements': [{'value': '-26.07', 'spread': '38.146', 'groupId': 'OG000'}, {'value': '-4.89', 'spread': '27.442', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Concentration of Apolipoproteins in the Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'Apolipoprotein AI at Week 4', 'categories': [{'measurements': [{'value': '-2.54', 'spread': '5.068', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '5.226', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein AI at Week 8', 'categories': [{'measurements': [{'value': '-4.25', 'spread': '7.541', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '6.540', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein AII at Week 4', 'categories': [{'measurements': [{'value': '-6.56', 'spread': '6.117', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '7.886', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein AII at Week 8', 'categories': [{'measurements': [{'value': '-8.17', 'spread': '7.326', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '8.773', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein B at Week 4', 'categories': [{'measurements': [{'value': '-3.48', 'spread': '7.515', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '8.674', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein B at Week 8', 'categories': [{'measurements': [{'value': '-6.57', 'spread': '9.763', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '8.054', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein B-48 at Week 4', 'categories': [{'measurements': [{'value': '-10.38', 'spread': '41.138', 'groupId': 'OG000'}, {'value': '39.56', 'spread': '84.921', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein B-48 at Week 8', 'categories': [{'measurements': [{'value': '-20.50', 'spread': '35.739', 'groupId': 'OG000'}, {'value': '28.49', 'spread': '71.554', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein B-100 at Week 4', 'categories': [{'measurements': [{'value': '-8.30', 'spread': '13.124', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '9.067', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein B-100 at Week 8', 'categories': [{'measurements': [{'value': '-9.09', 'spread': '13.453', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '14.516', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein CII at Week 4', 'categories': [{'measurements': [{'value': '-11.69', 'spread': '15.395', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '16.006', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein CII at Week 8', 'categories': [{'measurements': [{'value': '-17.80', 'spread': '17.579', 'groupId': 'OG000'}, {'value': '6.04', 'spread': '21.676', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein CIII at Week 4', 'categories': [{'measurements': [{'value': '-7.29', 'spread': '15.338', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '15.115', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein CIII at Week 8', 'categories': [{'measurements': [{'value': '-12.14', 'spread': '15.585', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '16.661', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein CII/III at Week 4', 'categories': [{'measurements': [{'value': '-4.02', 'spread': '13.076', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '18.066', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein CII/III at Week 8', 'categories': [{'measurements': [{'value': '-6.02', 'spread': '14.231', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '16.356', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein E at Week 4', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '19.222', 'groupId': 'OG000'}, {'value': '4.38', 'spread': '15.518', 'groupId': 'OG001'}]}]}, {'title': 'Apolipoprotein E at Week 8', 'categories': [{'measurements': [{'value': '-4.24', 'spread': '18.788', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '13.578', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'classes': [{'title': 'CM Fraction at Week 4', 'categories': [{'measurements': [{'value': '-37.40', 'spread': '50.191', 'groupId': 'OG000'}, {'value': '42.88', 'spread': '134.849', 'groupId': 'OG001'}]}]}, {'title': 'CM Fraction at Week 8', 'categories': [{'measurements': [{'value': '-33.40', 'spread': '54.049', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '56.198', 'groupId': 'OG001'}]}]}, {'title': 'VLDL Fraction at Week 4', 'categories': [{'measurements': [{'value': '-6.20', 'spread': '16.087', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '14.765', 'groupId': 'OG001'}]}]}, {'title': 'VLDL Fraction at Week 8', 'categories': [{'measurements': [{'value': '-9.88', 'spread': '17.551', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '13.808', 'groupId': 'OG001'}]}]}, {'title': 'LDL Fraction at Week 4', 'categories': [{'measurements': [{'value': '-4.58', 'spread': '10.413', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '9.059', 'groupId': 'OG001'}]}]}, {'title': 'LDL Fraction at Week 8', 'categories': [{'measurements': [{'value': '-7.43', 'spread': '9.993', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '11.430', 'groupId': 'OG001'}]}]}, {'title': 'HDL Fraction at Week 4', 'categories': [{'measurements': [{'value': '-4.31', 'spread': '5.517', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '5.893', 'groupId': 'OG001'}]}]}, {'title': 'HDL Fraction at Week 8', 'categories': [{'measurements': [{'value': '-6.33', 'spread': '6.567', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '7.687', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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).', 'unitOfMeasure': 'Percent of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 7 investigative sites in Japan, from 27 December 2016 to 30 August 2017.', 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-085 4 g', 'description': '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.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '11.28', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '11.67', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '11.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '168.9', 'spread': '6.05', 'groupId': 'BG000'}, {'value': '167.7', 'spread': '7.55', 'groupId': 'BG001'}, {'value': '168.2', 'spread': '6.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77.93', 'spread': '9.784', 'groupId': 'BG000'}, {'value': '77.13', 'spread': '12.507', 'groupId': 'BG001'}, {'value': '77.49', 'spread': '11.257', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.27', 'spread': '2.791', 'groupId': 'BG000'}, {'value': '27.39', 'spread': '3.746', 'groupId': 'BG001'}, {'value': '27.34', 'spread': '3.317', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Hyperlipemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.05', 'spread': '7.590', 'groupId': 'BG000'}, {'value': '7.76', 'spread': '5.847', 'groupId': 'BG001'}, {'value': '9.25', 'spread': '6.828', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean duration between start of study and first time of diagnosis of hyperlipemia was reported.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Frequency of Fish Intake', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Almost Every Day', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'About Every Two Days', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'About Once or Twice Per Week', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Rarely', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never smoked', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Current smoker', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drinking habit', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting Triglycerides', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '208.0', 'spread': '74.05', 'groupId': 'BG000'}, {'value': '214.7', 'spread': '73.12', 'groupId': 'BG001'}, {'value': '211.7', 'spread': '72.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligram (mg)/deciliter (dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cholesterol Concentration in Small Dense Low Density Lipoprotein (sdLDL) Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.285', 'spread': '5.9109', 'groupId': 'BG000'}, {'value': '32.981', 'spread': '9.1346', 'groupId': 'BG001'}, {'value': '31.760', 'spread': '7.8879', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides Concentration in sdLDL Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.778', 'spread': '1.8022', 'groupId': 'BG000'}, {'value': '7.320', 'spread': '2.0727', 'groupId': 'BG001'}, {'value': '7.074', 'spread': '1.9556', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Free Cholesterol Concentration in sdLDL Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.670', 'spread': '1.6883', 'groupId': 'BG000'}, {'value': '9.353', 'spread': '2.3705', 'groupId': 'BG001'}, {'value': '9.044', 'spread': '2.0986', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Phospholipid Concentration in sdLDL Fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.526', 'spread': '5.1749', 'groupId': 'BG000'}, {'value': '33.860', 'spread': '7.9633', 'groupId': 'BG001'}, {'value': '32.803', 'spread': '6.8824', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Particle Size of LDL(Cholesterol Monitor)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.712', 'spread': '0.4301', 'groupId': 'BG000'}, {'value': '25.681', 'spread': '0.4087', 'groupId': 'BG001'}, {'value': '25.695', 'spread': '0.4148', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Nanometer (nm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Particle Size of LDL (Triglycerides Monitor)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.378', 'spread': '1.0152', 'groupId': 'BG000'}, {'value': '29.005', 'spread': '0.8946', 'groupId': 'BG001'}, {'value': '29.173', 'spread': '0.9442', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Population Analysis Description: The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Particle Size of LDL (Free Cholesterol Monitor)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.560', 'spread': '0.4403', 'groupId': 'BG000'}, {'value': '25.492', 'spread': '0.4263', 'groupId': 'BG001'}, {'value': '25.523', 'spread': '0.4299', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Particle Size of LDL (Phospholipid Monitor)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.335', 'spread': '0.4431', 'groupId': 'BG000'}, {'value': '25.263', 'spread': '0.3945', 'groupId': 'BG001'}, {'value': '25.296', 'spread': '0.4147', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-07', 'size': 1417861, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-28T03:07', 'hasProtocol': True}, {'date': '2017-10-31', 'size': 907883, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-28T03:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2016-07-19', 'resultsFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-28', 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction', 'timeFrame': 'Baseline, Week 4, and Week 8', 'description': 'Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.'}, {'measure': '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', 'timeFrame': 'Baseline, Week 4, and Week 8', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8.'}, {'measure': 'Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8.'}, {'measure': 'Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8.'}, {'measure': 'Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'The reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8.'}, {'measure': 'Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Concentration of Lipids in the Blood', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Concentration of Apolipoproteins in the Blood', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudy 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants diagnosed as hyperlipidemia.\n2. Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the start of the observation period.\n3. Participants with fasting TG of 150≤ to \\<400 mg/dL measured at the start of the observation period at Visit 1 (Week -4).\n4. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.\n5. Participants who can provide written informed consent prior to the conduction of the clinical study procedures.\n6. Participants aged ≥20 years at the time of informed consent at Visit 1 (Week -4).\n\nExclusion Criteria:\n\n1. Participants who had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to the start of the observation period, or those who concurrently have the above disorders.\n2. Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to the start of the observation period, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder.\n3. Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to the start of observation period.\n4. Participants who received an eicosapentaenoic acid (EPA) preparation or an EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks prior to the start of observation period.\n5. Participants who started antidyslipidemic agents within 4 weeks prior to the start of observation period.\n6. Participants with severe hepatic impairment (e.g., Child-Pugh classification C).\n7. Participants who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency.\n8. Participants who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia.\n9. Diabetic participants who are currently receiving thiazolidine or insulin.\n10. Participants who are concurrently having hypertension of grade IIINote 1). Note 1: Participants with systolic blood pressure of ≥180 mm Hg or diastolic blood pressure of ≥110 mm Hg regardless of treatment with antihypertensive drugs.\n11. Participants who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol), or participants with or with a history of drug abuse or addiction.\n12. Pregnant, lactating or postmenopausal women.\n13. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters.\n14. Participants participating in other clinical studies.\n15. Participants assessed ineligible in the study by the principal investigator or the investigator."}, 'identificationModule': {'nctId': 'NCT02839902', 'acronym': 'LOTUS', 'briefTitle': 'Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood', 'orgStudyIdInfo': {'id': 'TAK-085-4002'}, 'secondaryIdInfos': [{'id': 'U1111-1185-0054', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-163322', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-085 4g', 'description': '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.', 'interventionNames': ['Drug: TAK-085']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.', 'interventionNames': ['Other: Not treated with omega-3-acid ethyl esters']}], 'interventions': [{'name': 'TAK-085', 'type': 'DRUG', 'description': 'Omega-3-acid ethyl esters (TAK-085) capsule', 'armGroupLabels': ['TAK-085 4g']}, {'name': 'Not treated with omega-3-acid ethyl esters', 'type': 'OTHER', 'description': 'Not treated with omega-3-acid ethyl esters', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Noda', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.94897, 'lon': 139.86793}}, {'city': 'Koga', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.18333, 'lon': 139.71667}}, {'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Fujimi', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.96851, 'lon': 139.58364}}, {'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}