Viewing Study NCT01674712

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Ignite Creation Date: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2026-03-06 @ 10:50 PM
Study NCT ID: NCT01674712
Status: COMPLETED
Last Update Posted: 2014-12-11
First Post: 2012-06-26
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'taco.baardman@abbott.com', 'title': 'Associate Director Clinical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the PI shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the PI shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fenofibrate/Simvastatin 145/20 mg', 'description': 'Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks', 'otherNumAtRisk': 111, 'otherNumAffected': 8, 'seriousNumAtRisk': 111, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks', 'otherNumAtRisk': 117, 'otherNumAffected': 7, 'seriousNumAtRisk': 117, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Fenofibrate/Simvastatin 145/40 mg', 'description': 'Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks', 'otherNumAtRisk': 113, 'otherNumAffected': 4, 'seriousNumAtRisk': 113, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks', 'otherNumAtRisk': 115, 'otherNumAffected': 9, 'seriousNumAtRisk': 115, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Fenofibrate 145 mg', 'description': 'Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks', 'otherNumAtRisk': 112, 'otherNumAffected': 15, 'seriousNumAtRisk': 112, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'MYOCARDIAL INFARCTION', 'notes': 'One Myocardial Infarction was fatal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'DIABETES MELLITUS INADEQUATE CONTROL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'TYPE 2 DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'VESTIBULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'INTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'UMBILICAL HERNIA, OBSTRUCTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'NON-SITE SPECIFIC INJURIES NEC', 'notes': 'One Injury was fatal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}, {'term': 'DIABETES MELLITUS MANAGEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Change of TG (Triglyceride)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate/Simvastatin 145/20 mg', 'description': 'Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks'}, {'id': 'OG001', 'title': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks'}, {'id': 'OG002', 'title': 'Fenofibrate/Simvastatin 145/40 mg', 'description': 'Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks'}, {'id': 'OG003', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks'}, {'id': 'OG004', 'title': 'Fenofibrate 145 mg', 'description': 'Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.6', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '48.8', 'groupId': 'OG001'}, {'value': '-27.3', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '34.3', 'groupId': 'OG003'}, {'value': '-21.6', 'spread': '34.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 12 weeks of treatment', 'description': 'Collection and measurement of blood samples.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis was done for the sample set of patients with 12 weeks' assessment."}, {'type': 'PRIMARY', 'title': 'Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate/Simvastatin 145/20 mg', 'description': 'Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks'}, {'id': 'OG001', 'title': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks'}, {'id': 'OG002', 'title': 'Fenofibrate/Simvastatin 145/40 mg', 'description': 'Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks'}, {'id': 'OG003', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks'}, {'id': 'OG004', 'title': 'Fenofibrate 145 mg', 'description': 'Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '16.5', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '12.5', 'groupId': 'OG003'}, {'value': '7.6', 'spread': '15.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 12 weeks of treatment', 'description': 'Collection and measurement of blood samples.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis was done for the sample set of patients with 12 weeks' assessment."}, {'type': 'PRIMARY', 'title': 'Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate/Simvastatin 145/20 mg', 'description': 'Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks'}, {'id': 'OG001', 'title': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks'}, {'id': 'OG002', 'title': 'Fenofibrate/Simvastatin 145/40 mg', 'description': 'Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks'}, {'id': 'OG003', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks'}, {'id': 'OG004', 'title': 'Fenofibrate 145 mg', 'description': 'Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '26.2', 'groupId': 'OG002'}, {'value': '-8.1', 'spread': '25.8', 'groupId': 'OG003'}, {'value': '30.3', 'spread': '35.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 12 weeks of treatment', 'description': 'Collection and measurement of blood samples.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Primary Analysis was done for the sample set of patients with 12 weeks' assessment."}, {'type': 'SECONDARY', 'title': 'Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of TC (Triglyceride) From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Apolipoprotein AI From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Apolipoprotein B From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Creatine Kinase (CK)', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT)', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Creatinine', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Total Bilirubin', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Cystatin C', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fenofibrate/Simvastatin 145/20 mg', 'description': 'Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks'}, {'id': 'FG001', 'title': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks'}, {'id': 'FG002', 'title': 'Fenofibrate/Simvastatin 145/40 mg', 'description': 'Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks'}, {'id': 'FG003', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks'}, {'id': 'FG004', 'title': 'Fenofibrate 145 mg', 'description': 'Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '116'}, {'groupId': 'FG004', 'numSubjects': '113'}]}, {'type': 'Full Analysis Subject Sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '110'}, {'groupId': 'FG003', 'numSubjects': '112'}, {'groupId': 'FG004', 'numSubjects': '111'}]}, {'type': 'Safety Subject Sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '115'}, {'groupId': 'FG004', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '106'}, {'groupId': 'FG003', 'numSubjects': '108'}, {'groupId': 'FG004', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 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{'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}, {'value': '556', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Fenofibrate/Simvastatin 145/20 mg', 'description': 'Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks'}, {'id': 'BG001', 'title': 'Simvastatin 20 mg', 'description': 'Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks'}, {'id': 'BG002', 'title': 'Fenofibrate/Simvastatin 145/40 mg', 'description': 'Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks'}, {'id': 'BG003', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks'}, {'id': 'BG004', 'title': 'Fenofibrate 145 mg', 'description': 'Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '10', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '59.3', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '60.4', 'spread': '9.0', 'groupId': 'BG004'}, {'value': '60.0', 'spread': '9.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '198', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '358', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '101', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '154', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Triglycerides (mmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '1.4', 'groupId': 'BG002'}, {'value': '2.7', 'spread': '1.0', 'groupId': 'BG003'}, {'value': '2.9', 'spread': '1.3', 'groupId': 'BG004'}, {'value': '2.7', 'spread': '1.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL Cholesterol (mmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '0.4', 'groupId': 'BG002'}, {'value': '2.7', 'spread': '0.4', 'groupId': 'BG003'}, {'value': '2.7', 'spread': '0.5', 'groupId': 'BG004'}, {'value': '2.7', 'spread': '0.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL Cholesterol (mmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '1.2', 'spread': '0.3', 'groupId': 'BG003'}, {'value': '1.2', 'spread': '0.3', 'groupId': 'BG004'}, {'value': '1.2', 'spread': '0.3', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis subject sample'}}, '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': 575}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-24', 'studyFirstSubmitDate': '2012-06-26', 'resultsFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-27', 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Change of TG (Triglyceride)', 'timeFrame': 'from baseline to 12 weeks of treatment', 'description': 'Collection and measurement of blood samples.'}, {'measure': 'Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)', 'timeFrame': 'from baseline to 12 weeks of treatment', 'description': 'Collection and measurement of blood samples.'}, {'measure': 'Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)', 'timeFrame': 'from baseline to 12 weeks of treatment', 'description': 'Collection and measurement of blood samples.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Percentage of TC (Triglyceride) From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Percentage of Apolipoprotein AI From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Percentage of Apolipoprotein B From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Adverse Events', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Creatine Kinase (CK)', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Plasma Creatinine', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Total Bilirubin', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}, {'measure': 'Cystatin C', 'timeFrame': '12 weeks', 'description': 'Collection and measurement of blood samples'}]}, 'conditionsModule': {'keywords': ['Fibrates', 'Dyslipidemia'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has been marketed in more than 80 countries since 1975. Simvastatin is also used for the treatment of patients with a high level of cholesterol. These have also been marketed worldwide for more than 20 years. It is important to treat high levels of fats in the blood because it has been shown that even mildly elevated level of lipids in the blood can lead to diseases of the blood vessels. It has been shown in several studies and in clinical practice that the combination of fenofibrate plus simvastatin can lead to improved effects on blood fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.\n2. between 18 (inclusive) and 80 years\n3. With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):\n\n * TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and\n * LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)\n4. High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent\n5. Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)\n\nExclusion Criteria:\n\n1. Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,\n2. Pregnant or lactating women,\n3. Unable or unwilling to comply with the protocol and the recommended diet,\n4. Likely to withdraw from the study before its completion,\n5. Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1'}, 'identificationModule': {'nctId': 'NCT01674712', 'briefTitle': 'A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.', 'orgStudyIdInfo': {'id': 'M13-377'}, 'secondaryIdInfos': [{'id': '2011-005924-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenofibrate/simvastatin 145/20 mg', 'interventionNames': ['Drug: Fixed Combination of Fenofibrate/simvastatin 145/20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin 20 mg', 'interventionNames': ['Drug: Simvastatin 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fenofibrate 145 mg', 'interventionNames': ['Drug: Fenofibrate 145 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Fenofibrate/simvastatin 145/40 mg', 'interventionNames': ['Drug: Fixed Combination of Fenofibrate/simvastatin 145/40 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin 40 mg', 'interventionNames': ['Drug: Simvastatin 40 mg']}], 'interventions': [{'name': 'Fixed Combination of Fenofibrate/simvastatin 145/20 mg', 'type': 'DRUG', 'description': 'Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks', 'armGroupLabels': ['Fenofibrate/simvastatin 145/20 mg']}, {'name': 'Simvastatin 20 mg', 'type': 'DRUG', 'description': 'Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks', 'armGroupLabels': ['Simvastatin 20 mg']}, {'name': 'Fenofibrate 145 mg', 'type': 'DRUG', 'description': 'Fenofibrate, tablet, 145 mg, once daily, 12 weeks', 'armGroupLabels': ['Fenofibrate 145 mg']}, {'name': 'Fixed Combination of Fenofibrate/simvastatin 145/40 mg', 'type': 'DRUG', 'description': 'Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks', 'armGroupLabels': ['Fenofibrate/simvastatin 145/40 mg']}, {'name': 'Simvastatin 40 mg', 'type': 'DRUG', 'description': 'simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks', 'armGroupLabels': ['Simvastatin 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7600', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77961', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1605DSX', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77957', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1657BHD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77958', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1722COV', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77960', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1878GEG', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77959', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B2800DGH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77969', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1179AAB', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site Reference ID/Investigator# 77967', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1181ACK', 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