Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-03-06 @ 2:47 AM
Study NCT ID:
NCT00166504
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2005-09-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D019821', 'term': 'Simvastatin'}, {'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': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, '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': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vytorin', 'description': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'otherNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 10 mg', 'otherNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'LDL-C Lowering Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vytorin', 'description': 'Ezetimibe 10 mg/Simvastatin 20 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-51', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-41', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-14.3', 'ciUpperLimit': '-5.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.3', 'estimateComment': 'Direction of the Comparison: Vytorin minus Atorvastatin.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'LDL-C = low density lipoprotein cholesterol, measured in mg/dl.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vytorin', 'description': 'Ezetimibe 10 mg/Simvastatin 20 mg'}, {'id': 'FG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 10 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After a 4-week diet/wash-out period, patients still at or above drug treatment thresholds established by National Cholesterol Education Program Adult Treatment Panel III Guidelines were randomized. Randomization was stratified according to LDL-C levels obtained 1 week pre-randomization: ≥130 to \\<160 mg/dL; ≥160 to \\<190 mg/dL; ≥190 mg/dL.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vytorin', 'description': 'Ezetimibe 10 mg/Simvastatin 20 mg'}, {'id': 'BG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 10 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata', 'classes': [{'title': '<130 mg/dl', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '>=130 to <160 mg/dl', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': '>=160 to <190 mg/dl', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': '>=190 mg/dl', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '25', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '25.2', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2005-09-09', 'resultsFirstSubmitDate': '2008-10-13', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2008-11-04', 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C Lowering Efficacy', 'timeFrame': '6 weeks', 'description': 'LDL-C = low density lipoprotein cholesterol, measured in mg/dl.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hypercholesterolemia\n* LDL-C \\>/= 130 mg/dL but \\</=250 mg/dL and triglyceride (TG) \\</= 350 mg/dL\n* National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline\n\nExclusion Criteria:\n\n* Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe'}, 'identificationModule': {'nctId': 'NCT00166504', 'briefTitle': 'Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia', 'orgStudyIdInfo': {'id': '0653A-092'}, 'secondaryIdInfos': [{'id': 'MK0653A-092'}, {'id': '2005_070'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vytorin', 'description': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'interventionNames': ['Drug: ezetimibe (+) simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'Atorvastatin 10 mg', 'interventionNames': ['Drug: atorvastatin']}], 'interventions': [{'name': 'ezetimibe (+) simvastatin', 'type': 'DRUG', 'otherNames': ['MK0653A', 'Vytorin®'], 'description': 'simvastatin/ezetimibe 10/20 mg', 'armGroupLabels': ['Vytorin']}, {'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor®'], 'description': 'atorvastatin 10 mg', 'armGroupLabels': ['Atorvastatin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}