Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-30 @ 6:30 AM
Study NCT ID:
NCT01408303
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2011-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Torbjörn Lundström', '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': {'description': 'A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.', 'eventGroups': [{'id': 'EG000', 'title': 'Epanova, 2 g', 'description': 'omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks', 'otherNumAtRisk': 215, 'otherNumAffected': 13, 'seriousNumAtRisk': 215, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Epanova, 4 g', 'description': 'omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks', 'otherNumAtRisk': 216, 'otherNumAffected': 36, 'seriousNumAtRisk': 216, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'placebo, 1 g capsule\n\nplacebo : 4 x 1 g capsule daily for 6 weeks', 'otherNumAtRisk': 215, 'otherNumAffected': 5, 'seriousNumAtRisk': 215, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 14.1)'}], 'seriousEvents': [{'term': 'musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version 14.1'}, {'term': 'diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version14.1)'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version14.1)'}, {'term': 'coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version14.1)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version14.1)'}, {'term': 'intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version 14.1'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (version14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Non-HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epanova 2 g', 'description': 'omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks'}, {'id': 'OG001', 'title': 'Epanova 4 g', 'description': 'omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo, 1 g capsule\n\nplacebo : 4 x 1 g capsule daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.86', 'groupId': 'OG000', 'lowerLimit': '-7.316', 'upperLimit': '-0.277'}, {'value': '-6.91', 'groupId': 'OG001', 'lowerLimit': '-10.204', 'upperLimit': '-3.504'}, {'value': '-0.91', 'groupId': 'OG002', 'lowerLimit': '-4.509', 'upperLimit': '2.822'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference relative to olive oil', 'paramValue': '-2.95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference relative to olive oil', 'paramValue': '-6.00', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.", 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/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': 'Epanova, 2 g + Statin', 'description': 'omega-3 carboxylic acids, 1 g capsule\n\nomega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks\n\nprescribe statin'}, {'id': 'FG001', 'title': 'Epanova, 4 g + Statin', 'description': 'omega-3 carboxylic acids, 1 g capsule\n\nomega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks\n\nprescribed statin'}, {'id': 'FG002', 'title': 'Olive Oil + Statin', 'description': 'olive oil, 1 g capsule\n\nolive oil: 4 x 1 g capsule daily for 6 weeks\n\nprescribed statin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '210'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The enrollment period started August 2011 and the last subject visit was May 2012. All subjects were qualified at the clinical site and eligibility was determined by each PI (96 sites)', 'preAssignmentDetails': 'Subjects underwent 6-week washout and diet stabilization period, discontinued use of any non-statin lipid therapies, continued their current statin regimen, and followed the NCEP TLC diet. Men and women considered to be at high risk for atherosclerotic CVD and who had high serum TG (≥200 mg/dL and \\<500 mg/dL) were eligible for randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '646', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Epanova, 2 g', 'description': 'omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks'}, {'id': 'BG001', 'title': 'Epanova, 4 g', 'description': 'omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'placebo, 1 g capsule\n\nplacebo : 4 x 1 g capsule daily for 6 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '403', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '9.95', 'groupId': 'BG000'}, {'value': '60.1', 'spread': '9.23', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '9.64', 'groupId': 'BG002'}, {'value': '60.8', 'spread': '9.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '646', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Baseline Analysis Population comprised the Safety Population defined as subjects who received at least 1 dose of investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 646}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-27', 'studyFirstSubmitDate': '2011-08-01', 'resultsFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-27', 'studyFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Non-HDL Cholesterol', 'timeFrame': '6 weeks', 'description': 'The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dyslipidemia', 'hyperlipidemia', 'cardiovascular risk'], 'conditions': ['Hypertriglyceridemia', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '26328624', 'type': 'DERIVED', 'citation': 'Dunbar RL, Nicholls SJ, Maki KC, Roth EM, Orloff DG, Curcio D, Johnson J, Kling D, Davidson MH. Effects of omega-3 carboxylic acids on lipoprotein particles and other cardiovascular risk markers in high-risk statin-treated patients with residual hypertriglyceridemia: a randomized, controlled, double-blind trial. Lipids Health Dis. 2015 Sep 2;14:98. doi: 10.1186/s12944-015-0100-8.'}, {'pmid': '23998969', 'type': 'DERIVED', 'citation': 'Maki KC, Orloff DG, Nicholls SJ, Dunbar RL, Roth EM, Curcio D, Johnson J, Kling D, Davidson MH. A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial). Clin Ther. 2013 Sep;35(9):1400-11.e1-3. doi: 10.1016/j.clinthera.2013.07.420. Epub 2013 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.', 'detailedDescription': 'The primary efficacy variable is serum non-HDL cholesterol. The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups. Baseline is defined as the average of Visits 2, 3 and 4 (Weeks -2, -1 and 0) and end-of-treatment is the average of Visits 5 and 6 (Weeks 5 and 6).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men or women, ≥18 years of age.\n2. Fasting triglyceride (TG) level ≥200 mg/dL and \\<500 mg/dL.\n3. The subject is a high risk for a future cardiovascular event.\n4. The subject is treated with a statin and at or near LDL-C goal.\n\nExclusion Criteria:\n\n1. Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.\n2. Use of fibrates, bile acid sequestrants, or niacin or its analogues (greater than 200 mg/d) during screening.\n3. Use of simvastatin 80 mg or Vytorin10/80 mg during screening.\n4. Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products.\n5. Use of any supplement for the purpose of lowering plasma cholesterol during screening.\n6. Use of weight loss drugs or programs during screening.\n7. Use of erythromycin, telithromycin, clarithromycin, cyclosporine, itraconazole, ketoconazole, protease inhibitors, or nefazodone during screening.\n8. Use of anticoagulants during screening.\n9. Use of oral or injected corticosteroids during screening.\n10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for \\>4 weeks at Visit 1, or is unstable during screening.\n11. Use of \\>750 mL/d grapefruit juice during screening.\n12. Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.\n13. History of pancreatitis.\n14. Type I diabetes mellitus, use of insulin, or HbA1c \\>10% at Visit 1.\n15. Poorly controlled hypertension\n16. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) \\>1.5xULN at Visit 2.\n17. Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.\n18. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.\n19. Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception.\n20. Creatine kinase \\>5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2.5 times ULN at Visit 2.\n21. Current or recent history (past 12 months) of drug or alcohol abuse.\n22. Exposure to any investigational agent within 4 weeks prior to Visit 1.\n23. 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': 'NCT01408303', 'acronym': 'ESPRIT', 'briefTitle': '[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 6-Week, Randomized, Double-Blind, Placebo(Olive Oil)-Controlled Study to Assess the Efficacy and Safety of Add-On Epanova® to Statin Therapy in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'OM-EPA-004'}, 'secondaryIdInfos': [{'id': 'OM-EPA-004', 'type': 'OTHER', 'domain': 'Omthera Pharmaceuticals, Inc.'}, {'id': 'NCT01408303', 'type': 'OTHER', 'domain': 'ClinicalTrials.gov Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Olive Oil', 'description': 'olive oil: 4 g/day + prescription statin', 'interventionNames': ['Drug: Olive oil, 4g']}, {'type': 'EXPERIMENTAL', 'label': 'Epanova, 2 g', 'description': 'omega-3-carboxylic acids, 2g/day + prescription statin', 'interventionNames': ['Drug: omega-3-carboxylic acids, 2g']}, {'type': 'EXPERIMENTAL', 'label': 'Epanova, 4 g', 'description': 'omega-3-carboxylic acids, 4g/day + prescription statin', 'interventionNames': ['Drug: omega-3-carboxylic acids, 4g']}], 'interventions': [{'name': 'Olive oil, 4g', 'type': 'DRUG', 'otherNames': ['Placebo comparator'], 'description': 'Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin', 'armGroupLabels': ['Olive Oil']}, {'name': 'omega-3-carboxylic acids, 2g', 'type': 'DRUG', 'otherNames': ['omega-3-carboxylic acids'], 'description': 'Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin', 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