Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT01070966
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2010-02-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vytorin Reexamination Study (0653A-174)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Vice President, Late Stage Development Group Leader', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Year 1 through Year 6. There were no SAE's reported in Year three.", 'eventGroups': [{'id': 'EG000', 'title': 'VYTORIN YEAR 1', 'description': 'Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VYTORIN YEAR 2', 'description': 'Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2', 'otherNumAtRisk': 933, 'otherNumAffected': 0, 'seriousNumAtRisk': 933, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'VYTORIN YEAR 4', 'description': 'Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4', 'otherNumAtRisk': 531, 'otherNumAffected': 0, 'seriousNumAtRisk': 531, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'VYTORIN YEAR 5', 'description': 'Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5', 'otherNumAtRisk': 380, 'otherNumAffected': 0, 'seriousNumAtRisk': 380, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'VYTORIN YEAR 6', 'description': 'Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6', 'otherNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VERTIGO POSITIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIABETIC RETINOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GASTRIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RETROPERITONEAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYELONEPHRITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIABETIC FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GOUTY ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SPINAL COLUMN STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CERVIX CARCINOMA RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 933, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 531, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2011', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Treated With VYTORIN', 'description': 'Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.72', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after the treatment discontinuation', 'description': 'Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline to Treatment in Lipid Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2011', 'groupId': 'OG000'}, {'value': '2011', 'groupId': 'OG001'}, {'value': '2011', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Baseline Lipid Parameters', 'description': 'Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.'}, {'id': 'OG001', 'title': 'Participants Treatment Lipid Parameters', 'description': 'Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.'}, {'id': 'OG002', 'title': 'Participants Percent Change'}], 'classes': [{'title': 'TC (n = 1965, 1993, 1956)', 'categories': [{'measurements': [{'value': '231.31', 'spread': '46.33', 'groupId': 'OG000'}, {'value': '173.00', 'spread': '40.78', 'groupId': 'OG001'}, {'value': '-23.90', 'spread': '17.45', 'groupId': 'OG002'}]}]}, {'title': 'HDL (n = 1805, 1782, 1705)', 'categories': [{'measurements': [{'value': '49.64', 'spread': '13.42', 'groupId': 'OG000'}, {'value': '49.85', 'spread': '13.17', 'groupId': 'OG001'}, {'value': '2.06', 'spread': '15.27', 'groupId': 'OG002'}]}]}, {'title': 'LDL (n = 1096, 1128, 1012)', 'categories': [{'measurements': [{'value': '151.32', 'spread': '39.09', 'groupId': 'OG000'}, {'value': '104.34', 'spread': '37.09', 'groupId': 'OG001'}, {'value': '-28.93', 'spread': '23.52', 'groupId': 'OG002'}]}]}, {'title': 'TG (n = 1843, 1824, 1766)', 'categories': [{'measurements': [{'value': '200.07', 'spread': '128.76', 'groupId': 'OG000'}, {'value': '168.33', 'spread': '102.82', 'groupId': 'OG001'}, {'value': '-7.37', 'spread': '41.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 5 years', 'description': 'The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\\[TG\\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VYTORIN® 10/10 mg/Day to 10/80 mg/Day', 'description': 'Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.'}], 'periods': [{'title': 'Participants for Safety Evaluation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2089'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2011'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Violation of inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'Off-label use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Duplicate Participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Violation inclusion criteria/off label', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'TMT given before date of contract', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}, {'title': 'Participants for Efficacy Evaluation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2011'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1929'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Lack of tmt period (<28 days)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'No efficacy evaluation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Efficacy evaluation window violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2011', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'VYTORIN® 10/10 mg/Day to 10/80 mg/Day', 'description': 'Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '10 ≤age <20', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '20 ≤age <30', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': '30 ≤age <40', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': '40 ≤age <50', 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}]}]}, {'title': '50 ≤age <60', 'categories': [{'measurements': [{'value': '598', 'groupId': 'BG000'}]}]}, {'title': '60 ≤age <70', 'categories': [{'measurements': [{'value': '600', 'groupId': 'BG000'}]}]}, {'title': '70 ≤age <80', 'categories': [{'measurements': [{'value': '256', 'groupId': 'BG000'}]}]}, {'title': '80 ≤age <90', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '930', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '1081', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2089}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2010-02-17', 'resultsFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2010-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-14', 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation', 'timeFrame': 'Up to 14 days after the treatment discontinuation', 'description': 'Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.'}, {'measure': 'Mean Percent Change From Baseline to Treatment in Lipid Parameters', 'timeFrame': 'Baseline and up to 5 years', 'description': 'The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\\[TG\\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atherosclerosis'], 'conditions': ['Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)']}, 'descriptionModule': {'briefSummary': 'This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time'}, 'identificationModule': {'nctId': 'NCT01070966', 'briefTitle': 'Vytorin Reexamination Study (0653A-174)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice', 'orgStudyIdInfo': {'id': '0653A-174'}, 'secondaryIdInfos': [{'id': '2010_010'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)', 'description': 'Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)'}, {'label': 'VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)', 'description': 'Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)'}, {'label': 'VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)', 'description': 'Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)'}, {'label': 'VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)', 'description': 'Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}