Viewing Study NCT00862251

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Ignite Creation Date: 2025-12-24 @ 11:52 PM
Ignite Modification Date: 2026-02-26 @ 4:13 PM
Study NCT ID: NCT00862251
Status: COMPLETED
Last Update Posted: 2024-05-16
First Post: 2009-03-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Bulgaria', 'Chile', 'Costa Rica', 'Croatia', 'Egypt', 'Estonia', 'Germany', 'Greece', 'Hungary', 'Italy', 'Latvia', 'Lithuania', 'Peru', 'Portugal', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], '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': '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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, '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': 'An investigator and/or his/her colleagues may publish the results for their study site independently after the multicenter publication, or 24 months after completion of the study, whichever comes first. The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All Patients as Treated (APaT) population was used for the analysis of safety data. The APaT population consisted of all randomized patients who received at\n\nleast one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks', 'otherNumAtRisk': 321, 'otherNumAffected': 0, 'seriousNumAtRisk': 321, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Doubling Statin Dose', 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10 mg tablets, taken once daily for six weeks.', 'otherNumAtRisk': 323, 'otherNumAffected': 0, 'seriousNumAtRisk': 323, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Statin Dose', 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.13', 'groupId': 'OG000', 'lowerLimit': '-25.95', 'upperLimit': '-20.31'}, {'value': '-8.37', 'groupId': 'OG001', 'lowerLimit': '-12.32', 'upperLimit': '-4.41'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent change in least-square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.76', 'ciLowerLimit': '-19.61', 'ciUpperLimit': '-9.91', 'statisticalMethod': 'Longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.'}, {'type': 'SECONDARY', 'title': 'In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Simvastatin Dose', 'description': 'simvastatin 40 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.59', 'groupId': 'OG000', 'lowerLimit': '-25.54', 'upperLimit': '-17.65'}, {'value': '-7.98', 'groupId': 'OG001', 'lowerLimit': '-13.57', 'upperLimit': '-2.38'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent change in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.62', 'ciLowerLimit': '-20.44', 'ciUpperLimit': '-6.79', 'statisticalMethod': 'Longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg'}, {'type': 'SECONDARY', 'title': 'In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Atorvastatin Dose', 'description': 'atorvastatin 20 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.58', 'groupId': 'OG000', 'lowerLimit': '-28.63', 'upperLimit': '-20.53'}, {'value': '-8.85', 'groupId': 'OG001', 'lowerLimit': '-14.47', 'upperLimit': '-3.23'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent change in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.73', 'ciLowerLimit': '-22.65', 'ciUpperLimit': '-8.81', 'statisticalMethod': 'Longitudinal Data Analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.13', 'groupId': 'OG000', 'lowerLimit': '-25.95', 'upperLimit': '-20.31'}, {'value': '-19.32', 'groupId': 'OG001', 'lowerLimit': '-22.14', 'upperLimit': '-16.51'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Change in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.81', 'ciLowerLimit': '-7.78', 'ciUpperLimit': '0.17', 'statisticalMethod': 'Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Statin Dose', 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '2.5', 'ciUpperLimit': '6.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.3', 'ciUpperLimit': '2.6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.'}, {'type': 'SECONDARY', 'title': 'In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Simvastatin Dose', 'description': 'simvastatin 40 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '2.3', 'ciUpperLimit': '8.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg'}, {'type': 'SECONDARY', 'title': 'In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Atorvastatin Dose', 'description': 'atorvastatin 20 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '1.9', 'ciUpperLimit': '6.6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Statin Dose', 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.21', 'spread': '17.69', 'groupId': 'OG000', 'lowerLimit': '-14.99', 'upperLimit': '-11.43'}, {'value': '-4.88', 'spread': '15.14', 'groupId': 'OG001', 'lowerLimit': '-7.37', 'upperLimit': '-2.39'}, {'value': '-10.58', 'spread': '15.18', 'groupId': 'OG002', 'lowerLimit': '-12.36', 'upperLimit': '-8.81'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.33', 'ciLowerLimit': '-11.38', 'ciUpperLimit': '-5.28', 'statisticalMethod': 'Longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.63', 'ciLowerLimit': '-5.13', 'ciUpperLimit': '-0.13', 'statisticalMethod': 'Longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Statin Dose', 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.51', 'groupId': 'OG000', 'lowerLimit': '-8.75', 'upperLimit': '-2.15'}, {'value': '-2.63', 'groupId': 'OG001', 'lowerLimit': '-7.23', 'upperLimit': '2.21'}, {'value': '-3.35', 'groupId': 'OG002', 'lowerLimit': '-6.66', 'upperLimit': '0.08'}]}]}], 'analyses': [{'pValue': '0.316', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.88', 'ciLowerLimit': '-8.53', 'ciUpperLimit': '2.77', 'statisticalMethod': 'Longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.356', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.16', 'ciLowerLimit': '-6.75', 'ciUpperLimit': '2.43', 'statisticalMethod': 'Longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Simvastatin', 'description': 'Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks'}, {'id': 'OG001', 'title': 'Doubling Statin Dose', 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10 mg tablets, taken once daily for six weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '3.21'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '-1.43', 'upperLimit': '3.43'}, {'value': '1.99', 'groupId': 'OG002', 'lowerLimit': '0.26', 'upperLimit': '3.73'}]}]}], 'analyses': [{'pValue': '0.756', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 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'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in TC/HDL-C Ratio', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Non-HDL-C/HDL-C Ratio', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo B)', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline Apolipoprotein A-I (Apo A-I)', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Apo B/Apo A-I Ratio', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)', 'timeFrame': 'Baseline and Week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular disorder'], 'conditions': ['Cardiovascular Disorder', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '26486166', 'type': 'DERIVED', 'citation': 'Le NA, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Effect of Switching From Statin Monotherapy to Ezetimibe/Simvastatin Combination Therapy Compared With Other Intensified Lipid-Lowering Strategies on Lipoprotein Subclasses in Diabetic Patients With Symptomatic Cardiovascular Disease. J Am Heart Assoc. 2015 Oct 20;4(10):e001675. doi: 10.1161/JAHA.114.001675.'}, {'pmid': '23866306', 'type': 'DERIVED', 'citation': 'Rosen JB, Jimenez JG, Pirags V, Vides H, Massaad R, Hanson ME, Brudi P, Triscari J. Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects. Lipids Health Dis. 2013 Jul 16;12:103. doi: 10.1186/1476-511X-12-103.'}, {'pmid': '23288881', 'type': 'DERIVED', 'citation': 'Rosen JB, Jimenez JG, Pirags V, Vides H, Hanson ME, Massaad R, McPeters G, Brudi P, Triscari J. A comparison of efficacy and safety of an ezetimibe/simvastatin combination compared with other intensified lipid-lowering treatment strategies in diabetic patients with symptomatic cardiovascular disease. Diab Vasc Dis Res. 2013 May;10(3):277-86. doi: 10.1177/1479164112465212. Epub 2013 Jan 3.'}, {'pmid': '23279632', 'type': 'DERIVED', 'citation': 'Jimenez JG, Rosen JB, Pirags V, Massaad R, Hanson ME, Brudi P, Triscari J. The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid-lowering treatment strategies in diabetic subjects with and without metabolic syndrome. Diabetes Obes Metab. 2013 Jun;15(6):513-22. doi: 10.1111/dom.12059. Epub 2013 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin\n* Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study\n* Patient is willing to remain abstinent or use birth control for the duration of the study\n* Patient has Diabetes Mellitus with cardiovascular disease\n\nExclusion Criteria:\n\n* Patient has sensitivity to certain common statin drugs\n* Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design\n* Patient consumes more than 2 alcoholic drinks per day\n* Patient is pregnant or breast-feeding\n* Patient has been treated with other investigational drugs within 30 days of first visit\n* Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin\n* Patient has congestive heart failure\n* Patient has uncontrolled high blood pressure\n* Patient has kidney disease\n* Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins\n* Patient has diabetes mellitus that is not well controlled\n* Patient is human immunodeficiency virus (HIV) positive\n* Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)\n* Patient is currently taking therapies that would increase the risk of muscle weakness\n* Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1\n* Patient is currently taking psyllium or other fiber-based laxatives'}, 'identificationModule': {'nctId': 'NCT00862251', 'briefTitle': 'Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose', 'orgStudyIdInfo': {'id': '0653A-133'}, 'secondaryIdInfos': [{'id': '2009_559', 'type': 'OTHER', 'domain': 'Merck Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe/simvastatin', 'interventionNames': ['Drug: ezetimibe (+) simvastatin', 'Drug: atorvastatin 10 mg or simvastatin 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doubling statin dose', 'interventionNames': ['Drug: simvastatin 40 mg or atorvastatin 20 mg', 'Drug: atorvastatin 10 mg or simvastatin 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'interventionNames': ['Drug: Rosuvastatin', 'Drug: atorvastatin 10 mg or simvastatin 20 mg']}], 'interventions': [{'name': 'ezetimibe (+) simvastatin', 'type': 'DRUG', 'otherNames': ['Vytorin'], 'description': 'ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.', 'armGroupLabels': ['Ezetimibe/simvastatin']}, {'name': 'simvastatin 40 mg or atorvastatin 20 mg', 'type': 'DRUG', 'otherNames': ['Lipitor, Zocor'], 'description': 'simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.', 'armGroupLabels': ['Doubling statin dose']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'rosuvastatin 10 mg tablets, taken once daily for six weeks.', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'atorvastatin 10 mg or simvastatin 20 mg', 'type': 'DRUG', 'otherNames': ['Lipitor, Zocor'], 'description': 'All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.', 'armGroupLabels': ['Doubling statin dose', 'Ezetimibe/simvastatin', 'Rosuvastatin']}]}, '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'}}}}