Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 5:23 PM
Study NCT ID:
NCT01370603
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2011-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'C583267', 'term': 'liptruzet'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, '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': '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. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '18 weeks', 'description': 'All Patients as Treated Population defined as all randomized participants who received at least 1 dose of study drug. Adverse events were reported by actual treatment regardless of study period or assigned treatment sequence. Not all\n\nrandomized participants entered Period 2 and therefore did not receive their assigned crossover treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks', 'otherNumAtRisk': 303, 'otherNumAffected': 0, 'seriousNumAtRisk': 303, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 20 mg once daily for 6 weeks', 'otherNumAtRisk': 313, 'otherNumAffected': 0, 'seriousNumAtRisk': 313, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-58.9', 'groupId': 'OG000', 'lowerLimit': '-60.9', 'upperLimit': '-56.9'}, {'value': '-58.7', 'groupId': 'OG001', 'lowerLimit': '-60.7', 'upperLimit': '-56.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.4', 'groupDescription': 'It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.0', 'groupId': 'OG000', 'lowerLimit': '-44.5', 'upperLimit': '-41.5'}, {'value': '-42.9', 'groupId': 'OG001', 'lowerLimit': '-44.4', 'upperLimit': '-41.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.1', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have\n\nsubstantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '4.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.4', 'groupId': 'OG000', 'lowerLimit': '-57.2', 'upperLimit': '-53.5'}, {'value': '-55.2', 'groupId': 'OG001', 'lowerLimit': '-57.0', 'upperLimit': '-53.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least-squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.2', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.7', 'groupId': 'OG000', 'lowerLimit': '-50.4', 'upperLimit': '-47.0'}, {'value': '-48.3', 'groupId': 'OG001', 'lowerLimit': '-50.0', 'upperLimit': '-46.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.5', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe/Atorvastatin Fixed Dose Combination', 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Co-Administration Ezetimibe and Atorvastatin', 'description': 'Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.2', 'groupId': 'OG000', 'lowerLimit': '-40.4', 'upperLimit': '-31.6'}, {'value': '-36.2', 'groupId': 'OG001', 'lowerLimit': '-38.8', 'upperLimit': '-33.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least-squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.0', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '4.9', 'statisticalMethod': 'constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Co-administration/Combination Sequence', 'description': 'Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination'}, {'id': 'FG001', 'title': 'Combination/Co-administration Sequence', 'description': 'Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Crossover Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Co-administration/Combination Sequence', 'description': 'Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination'}, {'id': 'BG001', 'title': 'Combination/Co-administration Sequence', 'description': 'Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '30 to 39 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': '60 to 64 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2011-06-08', 'resultsFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-21', 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.'}, {'measure': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.'}, {'measure': 'Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment', 'timeFrame': 'Baseline and Week 6', 'description': 'Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.'}, {'measure': 'Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment', 'timeFrame': 'Baseline and Week 6', 'description': 'Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '25431239', 'type': 'RESULT', 'citation': 'Bays HE, Chen E, Tomassini JE, McPeters G, Polis AB, Triscari J. Fixed-dose combination ezetimibe+atorvastatin lowers LDL-C equivalent to co-administered components in randomized trials: use of a dose-response model. Fundam Clin Pharmacol. 2015 Apr;29(2):209-18. doi: 10.1111/fcp.12096. Epub 2015 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* At low, moderate, or moderately high cardiovascular risk (according to National Cholesterol Education Program adult treatment panel III \\[NCEP ATP III\\] guidelines) and either statin-naïve with LDL-C ≥130 mg/dL for low risk or ≥100 mg/dL for moderate or moderately high risk OR on an allowable statin with on-therapy LDL-C ≥100 mg/dL in acceptable range and can safely discontinue and switch to study medication.\n* Is willing to maintain a cholesterol-lowering diet throughout the study.\n* Female of reproductive potential agrees to remain abstinent or to use (or have their partner use) 2 acceptable methods of birth control throughout the study.\n* Female receiving non-cyclical hormone therapy, if maintained on a stable dose and regimen for at least 8 weeks prior to the study and if willing to continue the same regimen throughout the study.\n* Off-therapy LDL-C levels are: for low risk patients, ≥130 mg/dL and ≤300 mg/dL; for moderate risk patients, ≥100 mg/dL and ≤300 mg/dL; for moderately high risk patients, ≥100 mg/dL and ≤275 mg/dL.\n* Has liver transaminases ≤2 X upper limit of normal (ULN) with no active liver disease.\n* Has creatine kinase (CK) levels ≤3 X ULN.\n* Has triglyceride (TG) concentrations ≤400 mg/dL.\n\nExclusion criteria:\n\n* Hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications, or a history of myopathy or rhabdomyolysis with ezetimibe or any statin.\n* Routinely consumes more than 2 alcoholic drinks per day (average \\>14 alcoholic drinks per week).\n* Is pregnant or lactating.\n* Has been treated with any other investigational drug within 30 days of the study.\n* Is high risk (according to NCEP ATP III guidelines), including but not limited to one or more of the following: diabetes mellitus (Type I or II), myocardial infarction, coronary artery bypass surgery, angioplasty, stable or unstable angina.\n* Has any of the following medical conditions: congestive heart failure; uncontrolled cardiac arrhythmias or recent significant changes in an electrocardiogram (ECG); homozygous familial hypercholesterolemia or has undergone LDL apheresis; partial ileal bypass, gastric bypass, or other significant intestinal malabsorption; uncontrolled hypertension; kidney disease; disease known to influence serum lipids or lipoproteins; hematologic, digestive, or central nervous system disorder; known to be human immunodeficiency virus (HIV) positive; history of malignancy ≤5 years prior to the study, except for adequately treated basal cell or squamous cell skin cancer or in situ\n\ncervical cancer; mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.\n\n\\- Taking prohibited medications/foods including: systemic azole antifungals (e.g., fluconazole, ketoconazole), erythromycin or clarithromycin, and cyclosporine; ritonavir and saquinavir or lopinavir; \\>5 cups of grapefruit juice per day; combination therapies of ezetimibe + atorvastatin (10/80 mg) or ezetimibe + rosuvastatin (10/20 mg or 10/40 mg); non-statin lipid-lowering agents including fish oils containing \\>900 mg/day of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA), red yeast extract, Cholestin™, bile acid sequestrants, other cholesterol-lowering agents, niacin (\\>200 mg/day), or fibrates; systemic corticosteroids; psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies known to affect serum lipid levels; orlistat or other anti-obesity medications and not maintained on a stable dose; any cyclical hormones; warfarin treatment without a stable dose or a stable International Normalized Ratio (INR).'}, 'identificationModule': {'nctId': 'NCT01370603', 'briefTitle': 'A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Double-Blind, Active-Controlled, Multicenter, Crossover Study to Evaluate the Efficacy of Ezetimibe/Atorvastatin 10 mg/40 mg Fixed-Dose Combination Tablet Compared to Co-Administration of Marketed Ezetimibe 10 mg and Atorvastatin 40 mg in Patients With Primary Hypercholesterolemia', 'orgStudyIdInfo': {'id': '0653C-190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ezetimibe and atorvastatin', 'description': 'Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 40 mg atorvastatin, and placebo to ezetimibe/atorvastatin.', 'interventionNames': ['Drug: Atorvastatin', 'Drug: Ezetimibe', 'Drug: Placebo to ezetimibe/atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Ezetimibe/atorvastatin combination', 'description': 'Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/40 mg, placebo to ezetimibe, and placebo to atorvastatin.', 'interventionNames': ['Drug: Ezetimibe/atorvastatin', 'Drug: Placebo to atorvastatin', 'Drug: Placebo to ezetimibe']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor®'], 'description': '40 mg tablet administered orally once daily', 'armGroupLabels': ['Ezetimibe and atorvastatin']}, {'name': 'Ezetimibe', 'type': 'DRUG', 'otherNames': ['Zetia®'], 'description': '10 mg tablet administered orally once daily', 'armGroupLabels': ['Ezetimibe and atorvastatin']}, {'name': 'Ezetimibe/atorvastatin', 'type': 'DRUG', 'otherNames': ['Liptruzet®', 'MK-0653C'], 'description': 'Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily', 'armGroupLabels': ['Ezetimibe/atorvastatin combination']}, {'name': 'Placebo to atorvastatin', 'type': 'DRUG', 'description': 'Administered orally once daily', 'armGroupLabels': ['Ezetimibe/atorvastatin combination']}, {'name': 'Placebo to ezetimibe', 'type': 'DRUG', 'description': 'Administered orally once daily', 'armGroupLabels': ['Ezetimibe/atorvastatin combination']}, {'name': 'Placebo to ezetimibe/atorvastatin', 'type': 'DRUG', 'description': 'Administered orally once daily', 'armGroupLabels': ['Ezetimibe and atorvastatin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}