Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 6:50 PM
Study NCT ID:
NCT02824432
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2016-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
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'}]}}, '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 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.71', 'spread': '3.466', 'groupId': 'OG000'}, {'value': '5.85', 'spread': '3.615', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.85', 'spread': '1.920', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '2.898', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.38', 'spread': '2.279', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '2.244', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4, and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.', 'unitOfMeasure': 'Percentage of dilation', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FMD With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '2.782', 'groupId': 'OG000'}, {'value': '-2.71', 'spread': '3.480', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '3.638', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '2.754', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.', 'unitOfMeasure': 'Percentage of dilation', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.01', 'spread': '143.217', 'groupId': 'OG000'}, {'value': '-36.70', 'spread': '52.824', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.37', 'spread': '218.483', 'groupId': 'OG000'}, {'value': '-8.19', 'spread': '52.111', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'FMD With 4-Hours Postprandial State at Baseline and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.49', 'spread': '2.489', 'groupId': 'OG000'}, {'value': '3.80', 'spread': '2.267', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.81', 'spread': '2.848', 'groupId': 'OG000'}, {'value': '4.95', 'spread': '2.516', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours after meal at Baseline and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.', 'unitOfMeasure': 'Percentage of dilation', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FMD With 4-Hours Postprandial State at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '1.284', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '3.519', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours after meal at Baseline and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.', 'unitOfMeasure': 'Percentage of dilation', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.62', 'spread': '31.542', 'groupId': 'OG000'}, {'value': '76.79', 'spread': '132.271', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours after meal at Baseline and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '176.8', 'spread': '59.18', 'groupId': 'OG000'}, {'value': '194.4', 'spread': '48.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178.2', 'spread': '75.49', 'groupId': 'OG000'}, {'value': '144.6', 'spread': '39.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '157.2', 'spread': '45.80', 'groupId': 'OG000'}, {'value': '144.9', 'spread': '43.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4, and Week 8', 'unitOfMeasure': 'mg/dL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TG Level With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '69.58', 'groupId': 'OG000'}, {'value': '-49.8', 'spread': '35.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.1', 'spread': '48.40', 'groupId': 'OG000'}, {'value': '-49.4', 'spread': '46.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'unitOfMeasure': 'mg/dL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '34.17', 'groupId': 'OG000'}, {'value': '-24.5', 'spread': '15.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.7', 'spread': '31.26', 'groupId': 'OG000'}, {'value': '-23.5', 'spread': '22.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and 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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '265.9', 'spread': '102.63', 'groupId': 'OG000'}, {'value': '278.2', 'spread': '70.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '266.1', 'spread': '75.18', 'groupId': 'OG000'}, {'value': '216.2', 'spread': '79.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '240.5', 'spread': '74.66', 'groupId': 'OG000'}, {'value': '202.3', 'spread': '78.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours after meal at Baseline, Week 4, and Week 8', 'unitOfMeasure': 'mg/dL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'spread': '89.29', 'groupId': 'OG000'}, {'value': '-62.1', 'spread': '54.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.7', 'spread': '89.40', 'groupId': 'OG000'}, {'value': '-75.9', 'spread': '57.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours after meal at Baseline and Week 4, and Week 8', 'unitOfMeasure': 'mg/dL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '29.15', 'groupId': 'OG000'}, {'value': '-22.4', 'spread': '18.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '35.29', 'groupId': 'OG000'}, {'value': '-27.2', 'spread': '21.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours after meal at Baseline and 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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.37', 'spread': '14.761', 'groupId': 'OG000'}, {'value': '57.32', 'spread': '12.274', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.54', 'spread': '11.493', 'groupId': 'OG000'}, {'value': '34.37', 'spread': '7.777', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.12', 'spread': '9.060', 'groupId': 'OG000'}, {'value': '33.32', 'spread': '8.609', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.', 'unitOfMeasure': 'microgram (μg)/milliliter (mL)', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.83', 'spread': '11.838', 'groupId': 'OG000'}, {'value': '-22.95', 'spread': '10.112', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.91', 'spread': '9.338', 'groupId': 'OG000'}, {'value': '-24.01', 'spread': '10.093', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.99', 'spread': '23.659', 'groupId': 'OG000'}, {'value': '-38.81', 'spread': '12.362', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.11', 'spread': '20.541', 'groupId': 'OG000'}, {'value': '-41.09', 'spread': '12.981', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '254.36', 'spread': '52.266', 'groupId': 'OG000'}, {'value': '253.08', 'spread': '69.609', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '238.69', 'spread': '65.009', 'groupId': 'OG000'}, {'value': '217.96', 'spread': '49.583', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243.71', 'spread': '76.318', 'groupId': 'OG000'}, {'value': '197.82', 'spread': '49.991', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.67', 'spread': '32.588', 'groupId': 'OG000'}, {'value': '-35.12', 'spread': '37.533', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.50', 'spread': '39.241', 'groupId': 'OG000'}, {'value': '-55.26', 'spread': '36.603', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.66', 'spread': '13.212', 'groupId': 'OG000'}, {'value': '-11.80', 'spread': '12.789', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.41', 'spread': '15.195', 'groupId': 'OG000'}, {'value': '-20.19', 'spread': '12.200', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.04', 'spread': '29.246', 'groupId': 'OG000'}, {'value': '55.62', 'spread': '26.992', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.07', 'spread': '34.223', 'groupId': 'OG000'}, {'value': '192.34', 'spread': '43.711', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134.94', 'spread': '41.173', 'groupId': 'OG000'}, {'value': '193.75', 'spread': '45.718', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.02', 'spread': '36.430', 'groupId': 'OG000'}, {'value': '136.72', 'spread': '45.047', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.98', 'spread': '32.197', 'groupId': 'OG000'}, {'value': '138.13', 'spread': '53.122', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.17', 'spread': '85.878', 'groupId': 'OG000'}, {'value': '297.49', 'spread': '140.921', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137.55', 'spread': '94.717', 'groupId': 'OG000'}, {'value': '305.92', 'spread': '153.767', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173.30', 'spread': '51.854', 'groupId': 'OG000'}, {'value': '145.43', 'spread': '45.037', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '207.04', 'spread': '51.493', 'groupId': 'OG000'}, {'value': '212.20', 'spread': '47.226', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '201.04', 'spread': '47.958', 'groupId': 'OG000'}, {'value': '207.53', 'spread': '48.728', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.74', 'spread': '42.605', 'groupId': 'OG000'}, {'value': '66.77', 'spread': '41.677', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.31', 'spread': '31.103', 'groupId': 'OG000'}, {'value': '62.11', 'spread': '51.694', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.', 'unitOfMeasure': 'μg/mL', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.32', 'spread': '29.608', 'groupId': 'OG000'}, {'value': '52.83', 'spread': '35.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.69', 'spread': '26.183', 'groupId': 'OG000'}, {'value': '51.54', 'spread': '44.898', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.265', 'spread': '0.1156', 'groupId': 'OG000'}, {'value': '0.240', 'spread': '0.1551', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.564', 'spread': '0.1990', 'groupId': 'OG000'}, {'value': '0.946', 'spread': '0.3722', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.579', 'spread': '0.1811', 'groupId': 'OG000'}, {'value': '1.043', 'spread': '0.3881', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.', 'unitOfMeasure': 'Ratio', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.299', 'spread': '0.1714', 'groupId': 'OG000'}, {'value': '0.706', 'spread': '0.2874', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.322', 'spread': '0.1301', 'groupId': 'OG000'}, {'value': '0.803', 'spread': '0.3241', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.', 'unitOfMeasure': 'Ratio', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '141.396', 'spread': '94.4914', 'groupId': 'OG000'}, {'value': '353.990', 'spread': '162.5131', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152.244', 'spread': '95.3802', 'groupId': 'OG000'}, {'value': '412.899', 'spread': '202.3624', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.697', 'spread': '0.2163', 'groupId': 'OG000'}, {'value': '0.619', 'spread': '0.2795', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.913', 'spread': '0.2874', 'groupId': 'OG000'}, {'value': '1.038', 'spread': '0.3726', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.881', 'spread': '0.2673', 'groupId': 'OG000'}, {'value': '1.119', 'spread': '0.4178', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.', 'unitOfMeasure': 'Ratio', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.216', 'spread': '0.1782', 'groupId': 'OG000'}, {'value': '0.419', 'spread': '0.2170', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.177', 'spread': '0.1512', 'groupId': 'OG000'}, {'value': '0.499', 'spread': '0.3002', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.', 'unitOfMeasure': 'Ratio', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.538', 'spread': '27.8356', 'groupId': 'OG000'}, {'value': '76.932', 'spread': '52.6408', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.797', 'spread': '26.0796', 'groupId': 'OG000'}, {'value': '93.582', 'spread': '69.6390', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.', '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. The number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More AEs Related to Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'OG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'FG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Major Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 7 investigative sites in Japan, from 04 August 2016 to 19 August 2017.', 'preAssignmentDetails': 'Participants with a historical diagnosis of hyperlipidemia were enrolled in one of two groups, omega-3-acid ethyl esters (TAK-085) 2 grams (g) and TAK-085 4 g treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-085 2 g', 'description': 'A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.'}, {'id': 'BG001', 'title': 'TAK-085 4 g', 'description': 'A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.5', 'spread': '11.14', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '7.94', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '9.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', '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': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '158.4', 'spread': '9.08', 'groupId': 'BG000'}, {'value': '162.1', 'spread': '9.21', 'groupId': 'BG001'}, {'value': '160.3', 'spread': '9.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.34', 'spread': '13.288', 'groupId': 'BG000'}, {'value': '71.94', 'spread': '14.636', 'groupId': 'BG001'}, {'value': '70.19', 'spread': '13.921', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.12', 'spread': '4.097', 'groupId': 'BG000'}, {'value': '27.14', 'spread': '3.483', 'groupId': 'BG001'}, {'value': '27.13', 'spread': '3.740', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Dyslipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.24', 'spread': '5.924', 'groupId': 'BG000'}, {'value': '9.51', 'spread': '5.173', 'groupId': 'BG001'}, {'value': '9.38', 'spread': '5.474', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean duration between start of study and first time of diagnosis of dyslipidemia was reported.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Postmenopausal Period', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '6.11', 'groupId': 'BG000'}, {'value': '16.6', 'spread': '5.88', 'groupId': 'BG001'}, {'value': '13.1', 'spread': '6.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This baseline characteristic was analyzed only in female participants with available data for analysis.'}, {'title': 'Frequency of Consumption of Fish', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Almost Every Day', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'About Every 2 days', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'About Once or Twice per Week', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Rarely', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', '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 History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Ex-Smoker', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drinking History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', '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': 'Triglyceride (TG) level (fasting)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '176.8', 'spread': '59.18', 'groupId': 'BG000'}, {'value': '194.4', 'spread': '48.57', 'groupId': 'BG001'}, {'value': '185.8', 'spread': '53.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligram (mg)/deciliter (dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TG level (4 h postprandial)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '265.9', 'spread': '102.63', 'groupId': 'BG000'}, {'value': '278.2', 'spread': '70.54', 'groupId': 'BG001'}, {'value': '272.2', 'spread': '86.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EPA/AA ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.265', 'spread': '0.1156', 'groupId': 'BG000'}, {'value': '0.240', 'spread': '0.1551', 'groupId': 'BG001'}, {'value': '0.252', 'spread': '0.1360', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EPA: Eicosapentaenoic acid, AA: Arachidonic acid', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-07', 'size': 2104034, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-10T02:10', 'hasProtocol': True}, {'date': '2017-11-14', 'size': 952899, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-10T02:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2016-05-20', 'resultsFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-31', 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4, and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.'}, {'measure': 'Change From Baseline in FMD With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.'}, {'measure': 'Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.'}], 'secondaryOutcomes': [{'measure': 'FMD With 4-Hours Postprandial State at Baseline and Week 8', 'timeFrame': '4-hours after meal at Baseline and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.'}, {'measure': 'Change From Baseline in FMD With 4-Hours Postprandial State at Week 8', 'timeFrame': '4-hours after meal at Baseline and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.'}, {'measure': 'Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8', 'timeFrame': '4-hours after meal at Baseline and Week 8', 'description': 'FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.'}, {'measure': 'Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4, and Week 8'}, {'measure': 'Change From Baseline in TG Level With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8'}, {'measure': 'Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8'}, {'measure': 'TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8', 'timeFrame': '4-hours after meal at Baseline, Week 4, and Week 8'}, {'measure': 'Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8', 'timeFrame': '4-hours after meal at Baseline and Week 4, and Week 8'}, {'measure': 'Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8', 'timeFrame': '4-hours after meal at Baseline and Week 4, and Week 8'}, {'measure': 'Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.'}, {'measure': 'Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.'}, {'measure': 'Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.'}, {'measure': 'Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.'}, {'measure': 'Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.'}, {'measure': 'Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.'}, {'measure': 'Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.'}, {'measure': 'Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.'}, {'measure': 'Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.'}, {'measure': 'Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.'}, {'measure': 'Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.'}, {'measure': 'Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.'}, {'measure': 'Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.'}, {'measure': 'Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.'}, {'measure': 'Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.'}, {'measure': 'Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline, Week 4 and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.'}, {'measure': 'Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.'}, {'measure': 'Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8', 'timeFrame': 'Prior to meal at Baseline and Week 4, and Week 8', 'description': 'Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.'}, {'measure': 'Number of Participants Reporting One or More Adverse Events (AEs)', 'timeFrame': 'Up to Week 8'}, {'measure': 'Number of Participants Reporting One or More AEs Related to Body Weight', 'timeFrame': 'Up to Week 8'}, {'measure': 'Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position', 'timeFrame': 'Up to Week 8'}, {'measure': 'Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position', 'timeFrame': 'Up to Week 8'}, {'measure': 'Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose', 'timeFrame': 'Up to Week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '32200533', 'type': 'DERIVED', 'citation': 'Teramoto T, Shibata H, Suzaki Y, Matsui S, Uemura N, Tomiyama H, Yamashina A. Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia. Adv Ther. 2020 May;37(5):2169-2183. doi: 10.1007/s12325-020-01286-1. Epub 2020 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.', 'detailedDescription': 'This is a multicenter, collaborative, randomized, open-label study designed to explore the effects of administration of omega-3-acid ethyl esters (TAK-085) \\[2 g (2 g PO QD) or 4 g (2 g PO BID) for 8 weeks\\] on vascular endothelial function, as measured by flow-mediated dilation (FMD), in patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and have concurrent hypertriglyceridemia.\n\nConsidering the potential bias by factors that affect FMD between treatment groups, stratified allocation will be performed with fasting triglyceride (TG) level as a factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement\n2. Participants with a fasting TG level of 150 -499 mg/dL at Visit 1 after informed consent (Day -29 to Day -1 before start of study drug administration)\n3. Participants receiving a stable dose of HMG-CoA reductase inhibitor therapy continuously for at least 4 weeks before informed consent at Visit 1 (Day -29 to Day -1 before start of study drug administration)\n4. Male or postmenopausal female participants\n5. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.\n6. Participants who can provide written informed consent prior to the conduction of the clinical research procedures\n7. Participants aged ≥20 years at the time of informed consent at Visit 1(Day -28 to Day 0 before the start of study drug administration)\n\nExclusion Criteria:\n\n1. Participants with a history of revascularization or those have had coronary artery disease (a definitive diagnosis of myocardial infarction, angina) within 24 weeks before informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)\n2. Participants who have undergo aortic aneurysmectomy within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those with concurrent aortic aneurysm\n3. Participants who have had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those who concurrently have the above disorders\n4. Participant with a fasting FMD level of 0% measured at the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)\n5. Participants in whom the type and dosage of HMG-CoA reductase inhibitors, antidiabetic drugs and antihypertensive drugs have been changed within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)\n6. Participants who have started anti dyslipidemic agents within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)\n7. Participants requiring a change in the dose of dyslipidemia therapeutic, antidiabetic, or antihypertensive drugs during the period between informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) and the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)\n8. Participants with severe hepatic dysfunction\n9. Participants with severe renal dysfunction (as an indicator, CKD category ≥G3b, equivalent to an A3)\n10. Participants who have been diagnosed with pancreatitis\n11. Participants who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia\n12. Participants with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism\n13. Participants with symptomatic Peripheral Arterial Disease (PAD)\n14. Participants with concurrent hypertension of grade II or higher Note 1) Note 1: Participants with systolic blood pressure of ≥160 mm Hg or diastolic BP of ≥100 mm Hg regardless of treatment with antihypertensive drugs\n15. 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 Note 2)\n16. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters-\n17. Participants who smoke\n18. Participants participating in other clinical studies\n19. Participants who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator"}, 'identificationModule': {'nctId': 'NCT02824432', 'acronym': 'Oasis Flow', 'briefTitle': 'Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Exploratory Study of the Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation', 'orgStudyIdInfo': {'id': 'TAK-085-4001'}, 'secondaryIdInfos': [{'id': 'U1111-1182-6745', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-163269', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-085 2g', 'description': 'A dose of 2 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered once a day immediately after meal.', 'interventionNames': ['Drug: TAK-085']}, {'type': 'EXPERIMENTAL', 'label': 'TAK-085 4g', 'description': 'A dose of 4 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered twice a day immediately after meal.', 'interventionNames': ['Drug: TAK-085']}], 'interventions': [{'name': 'TAK-085', 'type': 'DRUG', 'description': 'TAK-085 capsules', 'armGroupLabels': ['TAK-085 2g', 'TAK-085 4g']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Ōita', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}], 'overallOfficials': [{'name': 'Study 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'}}}}