Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01242527
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2010-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Epanova® for Lowering Very High Triglycerides
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Torbjörn Lundström, Medical Science Director', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Individual investigators may publish data arising from their own subjects. The PI will provide the Sponsor with copies of written publications (including abstracts and posters)at least 60 days in advance of submission. Data will be reviewed by all participating investigators prior to publication. The Sponsor will have 60 days to review all definitive publications, such as manuscripts and book chapters, and a minimum of 30 days to review all abstracts.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Olive Oil (Placebo)', 'description': 'placebo : 4 capsules (1g) daily for 12 weeks', 'otherNumAtRisk': 99, 'otherNumAffected': 5, 'seriousNumAtRisk': 99, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Epanova 2 g', 'description': 'omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks', 'otherNumAtRisk': 100, 'otherNumAffected': 23, 'seriousNumAtRisk': 100, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Epanova 3 g', 'description': 'omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks', 'otherNumAtRisk': 101, 'otherNumAffected': 18, 'seriousNumAtRisk': 101, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Epanova 4 g', 'description': 'omefas : 4 capsules (1g)daily for 12 weeks', 'otherNumAtRisk': 99, 'otherNumAffected': 16, 'seriousNumAtRisk': 99, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Serum Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Olive Oil (Placebo)', 'description': 'placebo : 4 capsules (1g) daily for 12 weeks'}, {'id': 'OG001', 'title': 'Epanova 2 g', 'description': 'omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks'}, {'id': 'OG002', 'title': 'Epanova 3 g', 'description': 'omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks'}, {'id': 'OG003', 'title': 'Epanova 4 g', 'description': 'omefas : 4 capsules (1g)daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.26', 'groupId': 'OG000', 'lowerLimit': '-13.07', 'upperLimit': '5.44'}, {'value': '-25.94', 'groupId': 'OG001', 'lowerLimit': '-32.84', 'upperLimit': '-18.33'}, {'value': '-25.46', 'groupId': 'OG002', 'lowerLimit': '-32.44', 'upperLimit': '-17.75'}, {'value': '-30.86', 'groupId': 'OG003', 'lowerLimit': '-37.32', 'upperLimit': '-23.74'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Placebo adjusted % change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.68', 'ciLowerLimit': '-40.70', 'ciUpperLimit': '-2.89', 'pValueComment': "P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil", 'estimateComment': 'ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors', 'statisticalMethod': 'ANCOVA p-value on ranked data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Placebo adjusted % change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.19', 'ciLowerLimit': '-40.32', 'ciUpperLimit': '-2.29', 'pValueComment': "P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil", 'estimateComment': 'ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors', 'statisticalMethod': 'ANCOVA p-value on ranked data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Placebo adjusted % change from baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.60', 'ciLowerLimit': '-45.12', 'ciUpperLimit': '-8.38', 'pValueComment': "P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil", 'estimateComment': 'ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors', 'statisticalMethod': 'ANCOVA p-value on ranked data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olive Oil (Placebo Control)', 'description': 'placebo : 4 capsules (1g) daily for 12 weeks'}, {'id': 'FG001', 'title': 'Epanova 2 g', 'description': 'omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks'}, {'id': 'FG002', 'title': 'Epanova 3 g', 'description': 'omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks'}, {'id': 'FG003', 'title': 'Epanova 4 g', 'description': 'omefas : 4 capsules (1g)daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '101'}, {'groupId': 'FG003', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The enrollment period started April 2011 and the last subject visit was February 2012. All subjects were qualified at the clinical site and eligibility was determined by each PI (74 US and International clinical sites).', 'preAssignmentDetails': 'Subjects who needed to washout omega-3 drugs/supplements or adjust or add a permitted statin, CAI or combination had an 8-week screening. All other subjects, including those on a stable statin, CAI or statin-CAI, or who needed to washout of bile acid sequestrants, fibrates, niacin and other lipid altering supplements had a 4-week screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '399', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Olive Oil (Placebo)', 'description': 'placebo : 4 capsules (1g) daily for 12 weeks'}, {'id': 'BG001', 'title': 'Epanova 2 g', 'description': 'omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks'}, {'id': 'BG002', 'title': 'Epanova 3 g', 'description': 'omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks'}, {'id': 'BG003', 'title': 'Epanova 4 g', 'description': 'omefas : 4 capsules (1g)daily for 12 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '10.59', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '9.79', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '8.75', 'groupId': 'BG002'}, {'value': '52.9', 'spread': '10.92', 'groupId': 'BG003'}, {'value': '51.5', 'spread': '10.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '307', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '374', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2010-11-15', 'resultsFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-27', 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Serum Triglycerides', 'timeFrame': '12 weeks', 'description': 'The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dyslipidemia', 'hyperlipidemia', 'omega-3 carboxylic acid'], 'conditions': ['Severe Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '24528690', 'type': 'DERIVED', 'citation': 'Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014 Jan-Feb;8(1):94-106. doi: 10.1016/j.jacl.2013.10.003. Epub 2013 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women, \\>=18 years of age.\n* Very high serum TG values in the range \\>=500 mg/dL and \\<2000 mg/dL (\\>=5.65 mmol/L and \\<22.60 mmol/L)\n\nExclusion Criteria:\n\n* Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.\n* Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.\n* Unable to discontinue use of omega-3 drugs/supplements.\n* Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins \\<200 mg), or any supplement used to alter lipid metabolism.\n* Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods.\n* Use of tamoxifen, estrogens or progestins that has not been stable for \\>4 weeks prior to Visit 1.\n* Use of oral or injected corticosteroids or anabolic steroids.\n* History of pancreatitis.\n* History of symptomatic gallstone disease, unless treated with cholecystectomy.\n* Uncontrolled diabetes.\n* Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH).\n* History of cancer (other than basal cell carcinoma) in the past 2 years.\n* Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1.\n* Use of anticoagulants (e.g. warfarin \\[Coumadin®\\], coumarin, heparin, enoxaparin, clopidogrel).\n* Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1.\n* Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.\n* Poorly controlled hypertension.\n* Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range.\n* Recent history (past 12 months) of drug abuse or alcohol abuse.\n* Exposure to any investigational product, within 4 weeks prior to Visit 1.\n* Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk"}, 'identificationModule': {'nctId': 'NCT01242527', 'acronym': 'EVOLVE', 'briefTitle': 'Epanova® for Lowering Very High Triglycerides', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia', 'orgStudyIdInfo': {'id': 'OM-EPA-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Epanova 2 g', 'interventionNames': ['Drug: omefas']}, {'type': 'EXPERIMENTAL', 'label': 'Epanova 3 g', 'interventionNames': ['Drug: omefas']}, {'type': 'EXPERIMENTAL', 'label': 'Epanova 4 g', 'interventionNames': ['Drug: omefas']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': '4 capsules (1g) daily for 12 weeks', 'armGroupLabels': ['placebo']}, {'name': 'omefas', 'type': 'DRUG', 'description': '2 capsules (1g) + 2 placebo daily for 12 weeks', 'armGroupLabels': ['Epanova 2 g']}, {'name': 'omefas', 'type': 'DRUG', 'description': '3 capsules (1g) + 1 placebo daily for 12 weeks', 'armGroupLabels': ['Epanova 3 g']}, {'name': 'omefas', 'type': 'DRUG', 'description': '4 capsules (1g)daily for 12 weeks', 'armGroupLabels': ['Epanova 4 g']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06040', 'city': 'Manchester', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.77593, 'lon': -72.52148}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '34461', 'city': 'Summerfield', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.00859, 'lon': -82.03481}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '38654', 'city': 'Olive Branch', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 34.96176, 'lon': -89.82953}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19446', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '6500', 'city': 'Baja', 'country': 'Hungary', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1115', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1125', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '4043', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3980', 'city': 'Sátoraljaújhely', 'country': 'Hungary', 'geoPoint': {'lat': 48.39492, 'lon': 21.65871}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '3800', 'city': 'Szikszó', 'country': 'Hungary', 'geoPoint': {'lat': 48.2, 'lon': 20.93333}}, {'zip': '132001', 'city': 'Karnāl', 'state': 'Haryana', 'country': 'India', 'geoPoint': {'lat': 29.69197, 'lon': 76.98448}}, {'zip': '560003', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560054', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560043', 'city': 'Banswada', 'state': 'Karnataka', 'country': 'India'}, {'zip': '452014', 'city': 'Indore', 'state': 'Madhya Pradesh', 'country': 'India', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'zip': '411005', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '302015', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '600010', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '395007', 'city': 'Surat', 'country': 'India', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9711SG', 'city': 'Groningen', 'country': 'Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3004BA', 'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3021HC', 'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '129090', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630068', 'city': 'Novosibirsk', 'country': 'Russia', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '192288', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196084', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '61037', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61039', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61176', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '03115', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '03680', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '69118', 'city': 'Zaporizhzhya', 'country': 'Ukraine', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}], 'overallOfficials': [{'name': 'Michael H Davidson, MD, FACC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Omthera Pharmaceuticals, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}