Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 5:41 AM
Study NCT ID:
NCT01414192
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'There was no plan to systematically collect adverse events for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ezetimibe Monotherapy With Prior Treatment', 'description': 'Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Cardiovascular (CV) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '424', 'groupId': 'OG002'}, {'value': '1726', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG001', 'title': 'Ezetimibe Monotherapy With Prior Treatment', 'description': 'Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'OG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.91', 'groupId': 'OG000', 'lowerLimit': '3.95', 'upperLimit': '14.14'}, {'value': '10.79', 'groupId': 'OG001', 'lowerLimit': '6.39', 'upperLimit': '17.05'}, {'value': '12.77', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '20.74'}, {'value': '13.4', 'groupId': 'OG003', 'lowerLimit': '10.38', 'upperLimit': '17.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'description': 'Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.', 'unitOfMeasure': 'Events per 1000 patient-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data for endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '2150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG001', 'title': 'Ezetimibe Monotherapy With Prior Treatment', 'description': 'Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG002', 'title': 'Ezetimibe Plus Statin or Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin or were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.4', 'groupId': 'OG000', 'lowerLimit': '-51.6', 'upperLimit': '8.2'}, {'value': '-7.1', 'groupId': 'OG001', 'lowerLimit': '-45.6', 'upperLimit': '47.0'}, {'value': '-30.7', 'groupId': 'OG002', 'lowerLimit': '-63.6', 'upperLimit': '16.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CV Risk Factors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '424', 'groupId': 'OG002'}, {'value': '1726', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG001', 'title': 'Ezetimibe Monotherapy With Prior Treatment', 'description': 'Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'OG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'classes': [{'title': '0 risk factors', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '11.3', 'groupId': 'OG002'}, {'value': '11.2', 'groupId': 'OG003'}]}]}, {'title': '1 risk factor', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}, {'value': '21.8', 'groupId': 'OG003'}]}]}, {'title': '2 risk factors', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '32.5', 'groupId': 'OG002'}, {'value': '31.9', 'groupId': 'OG003'}]}]}, {'title': '3 risk factors', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}, {'value': '25.9', 'groupId': 'OG002'}, {'value': '23.6', 'groupId': 'OG003'}]}]}, {'title': '4 risk factors', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '9.2', 'groupId': 'OG003'}]}]}, {'title': '5 risk factors', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}, {'value': '2.2', 'groupId': 'OG003'}]}]}, {'title': '6 risk factors', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At enrollment (baseline)', 'description': "Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol \\& substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1065', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}, {'value': '1726', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe Monotherapy With or Without Prior Treatment', 'description': 'Enrolled participants with or without prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG001', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'OG002', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'classes': [{'title': '12 months (n=857; 446; 1755)', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '57.4', 'groupId': 'OG002'}]}]}, {'title': '24 months (n=722; 380; 1563)', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '58.6', 'groupId': 'OG002'}]}]}, {'title': '36 months (n=433; 248; 1025)', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}, {'value': '60.1', 'groupId': 'OG002'}]}]}, {'title': '48 months (n=203; 127; 437)', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '16.6', 'groupId': 'OG001'}, {'value': '57.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'description': "Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1 Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '424', 'groupId': 'OG002'}, {'value': '1726', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG001', 'title': 'Ezetimibe Monotherapy With Prior Treatment', 'description': 'Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'OG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '13.4', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '11.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'description': 'The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with available data.'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}, {'value': '1369', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG001', 'title': 'Ezetimibe Monotherapy With Prior Treatment', 'description': 'Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'OG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'OG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'classes': [{'categories': [{'measurements': [{'value': '506.54', 'groupId': 'OG000', 'lowerLimit': '185.89', 'upperLimit': '1102.53'}, {'value': '689.66', 'groupId': 'OG001', 'lowerLimit': '330.72', 'upperLimit': '1268.30'}, {'value': '817.81', 'groupId': 'OG002', 'lowerLimit': '373.95', 'upperLimit': '1552.46'}, {'value': '761.77', 'groupId': 'OG003', 'lowerLimit': '524.37', 'upperLimit': '1069.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'description': 'The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.', 'unitOfMeasure': 'Deaths per 100,000 patient-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'FG001', 'title': 'Ezetimibe Monotherpay With Prior Treatment', 'description': 'Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'FG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'FG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '490'}, {'groupId': 'FG001', 'numSubjects': '575'}, {'groupId': 'FG002', 'numSubjects': '424'}, {'groupId': 'FG003', 'numSubjects': '1726'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '490'}, {'groupId': 'FG001', 'numSubjects': '575'}, {'groupId': 'FG002', 'numSubjects': '424'}, {'groupId': 'FG003', 'numSubjects': '1726'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Data was provided by French physicians for participants who were being administered Ezetrol® monotherapy, or Ezetrol® coadministered with a statin, or Inegy® (a fixed-dose combination of ezetimibe and simvastatin.', 'preAssignmentDetails': 'All participants who met inclusion criteria and contributed to at least one type of follow-up data in the form of an interview or physician questionnaire were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'BG000'}, {'value': '575', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}, {'value': '1726', 'groupId': 'BG003'}, {'value': '3215', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ezetimibe Monotherapy Without Prior Treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'BG001', 'title': 'Ezetimibe Monotherpay With Prior Treatment', 'description': 'Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'id': 'BG002', 'title': 'Ezetimibe Plus Statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin'}, {'id': 'BG003', 'title': 'Ezetimibe/Simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '10.6', 'groupId': 'BG003'}, {'value': '61.5', 'spread': '10.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '728', 'groupId': 'BG003'}, {'value': '1459', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '998', 'groupId': 'BG003'}, {'value': '1756', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2011-08-09', 'resultsFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-02', 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Cardiovascular (CV) Events', 'timeFrame': 'up to 48 months', 'description': 'Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months', 'timeFrame': 'Baseline and Month 12', 'description': 'LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.'}, {'measure': 'Percentage of Participants With CV Risk Factors', 'timeFrame': 'At enrollment (baseline)', 'description': "Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol \\& substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group."}, {'measure': 'Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months', 'timeFrame': 'up to 48 months', 'description': "Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded."}, {'measure': 'Percentage of Participants With at Least 1 Discontinuation of Study Drug', 'timeFrame': 'up to 48 months', 'description': 'The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.'}, {'measure': 'Mortality Rate', 'timeFrame': 'up to 48 months', 'description': 'The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '27919355', 'type': 'RESULT', 'citation': 'Ferrieres J, Dallongeville J, Rossignol M, Benichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Resident of Continental France\n* Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®)\n* Incident treatment with ezetimibe at the time of recruitment into the study\n\nExclusion criteria:\n\n* Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence\n* Participating in a clinical trial\n* Unable to read the information letter in French and/or unable to participate in the telephone interview in French'}, 'identificationModule': {'nctId': 'NCT01414192', 'acronym': 'MOBS', 'briefTitle': 'A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®', 'orgStudyIdInfo': {'id': '0653A-204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ezetimibe monotherapy without prior treatment', 'description': 'Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'label': 'Ezetimibe monotherpay with prior treatment', 'description': 'Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).'}, {'label': 'Ezetimibe plus statin', 'description': 'Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin.'}, {'label': 'Ezetimibe/simvastatin', 'description': 'Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}