Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00871351
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2009-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': "The investigator agrees not to publish/present any interim results of the study without Sponsor's prior written consent. The investigator further agrees to provide to the sponsor 45 days prior to submission, review copies of abstracts/manuscripts that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor for the purpose of making good faith efforts to discuss and resolve any such issues or disagreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Randomized participants', 'eventGroups': [{'id': 'EG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg', 'otherNumAtRisk': 47, 'otherNumAffected': 13, 'seriousNumAtRisk': 47, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg', 'otherNumAtRisk': 46, 'otherNumAffected': 5, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg', 'otherNumAtRisk': 32, 'otherNumAffected': 9, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Carcinoid tumour of the gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.8', 'groupId': 'OG000', 'lowerLimit': '-29.2', 'upperLimit': '-22.4'}, {'value': '-15.1', 'groupId': 'OG001', 'lowerLimit': '-18.6', 'upperLimit': '-11.7'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '-3.3', 'upperLimit': '4.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.6', 'ciLowerLimit': '-15.4', 'ciUpperLimit': '-5.8', 'statisticalMethod': "Hochberg's method", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.5', 'ciLowerLimit': '-31.8', 'ciUpperLimit': '-21.2', 'statisticalMethod': "Hochberg's method", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'End of Week 4 to Week 16 or discontinuation', 'description': 'LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.6', 'groupId': 'OG000', 'lowerLimit': '-52.9', 'upperLimit': '-46.4'}, {'value': '-41.1', 'groupId': 'OG001', 'lowerLimit': '-44.4', 'upperLimit': '-37.9'}, {'value': '-30.5', 'groupId': 'OG002', 'lowerLimit': '-34.4', 'upperLimit': '-26.6'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Hochberg's method", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': "Hochberg's method", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'End of washout period to Week 16 or discontinuation', 'description': 'LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16 or discontinuation', 'description': 'LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).\n\nTarget values:\n\nFor participants with history of coronary artery disease: \\<100 mg/dL;\n\nfor participants with at least 3 cardiovascular (CV) risk factors: \\<120 mg/dL;\n\nfor participants with 1-2 CV risk factors: \\<140 mg/dL;\n\nfor participants with no CV risk factors: \\<160 mg/dL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-18.0', 'groupId': 'OG000', 'lowerLimit': '-20.7', 'upperLimit': '-15.2'}, {'value': '-10.3', 'groupId': 'OG001', 'lowerLimit': '-13.1', 'upperLimit': '-7.4'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '5.5'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-14.4', 'upperLimit': '12.8'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '11.4'}, {'value': '14.7', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '27.0'}]}]}, {'title': 'High-Density Lipoprotein Cholesterol (HDL-C)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '8.2'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '3.5'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '6.4'}]}]}, {'title': 'Non-HDL-C', 'categories': [{'measurements': [{'value': '-25.0', 'groupId': 'OG000', 'lowerLimit': '-28.5', 'upperLimit': '-21.5'}, {'value': '-13.7', 'groupId': 'OG001', 'lowerLimit': '-17.0', 'upperLimit': '-10.3'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '-2.6', 'upperLimit': '6.5'}]}]}, {'title': 'High Sensitivity C-Reactive Protein (Hs-CRP)', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '-43.2', 'upperLimit': '141.3'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '-24.1', 'upperLimit': '43.9'}, {'value': '25.7', 'groupId': 'OG002', 'lowerLimit': '-4.8', 'upperLimit': '56.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Week 4 to Week 16 or discontinuation', 'description': 'Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Lipids and Hs-CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'OG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-39.9', 'groupId': 'OG000', 'lowerLimit': '-42.1', 'upperLimit': '-37.7'}, {'value': '-32.8', 'groupId': 'OG001', 'lowerLimit': '-35.8', 'upperLimit': '-29.7'}, {'value': '-24.4', 'groupId': 'OG002', 'lowerLimit': '-27.9', 'upperLimit': '-21.0'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-25.3', 'groupId': 'OG000', 'lowerLimit': '-36.0', 'upperLimit': '-14.6'}, {'value': '-18.8', 'groupId': 'OG001', 'lowerLimit': '-29.8', 'upperLimit': '-7.8'}, {'value': '-12.0', 'groupId': 'OG002', 'lowerLimit': '-21.3', 'upperLimit': '-2.7'}]}]}, {'title': 'High-Density Lipoprotein Cholesterol (HDL-C)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '14.5'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '11.0'}, {'value': '9.9', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '16.2'}]}]}, {'title': 'Non-HDL-C', 'categories': [{'measurements': [{'value': '-50.1', 'groupId': 'OG000', 'lowerLimit': '-52.7', 'upperLimit': '-47.6'}, {'value': '-41.4', 'groupId': 'OG001', 'lowerLimit': '-44.8', 'upperLimit': '-37.9'}, {'value': '-31.3', 'groupId': 'OG002', 'lowerLimit': '-35.4', 'upperLimit': '-27.1'}]}]}, {'title': 'High Sensitivity C-reactive Protein (Hs-CRP)', 'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '-84.4', 'upperLimit': '230.4'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-36.3', 'upperLimit': '30.4'}, {'value': '-13.6', 'groupId': 'OG002', 'lowerLimit': '-39.7', 'upperLimit': '12.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of washout to Week 16 or discontinuation', 'description': 'Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'FG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'FG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'BG001', 'title': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'BG002', 'title': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '61.0', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2009-03-26', 'resultsFirstSubmitDate': '2011-05-16', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-26', 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values', 'timeFrame': 'End of Week 4 to Week 16 or discontinuation', 'description': 'LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).'}], 'secondaryOutcomes': [{'measure': 'Percent Change in LDL-C', 'timeFrame': 'End of washout period to Week 16 or discontinuation', 'description': 'LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).'}, {'measure': 'Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values', 'timeFrame': 'Week 16 or discontinuation', 'description': 'LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).\n\nTarget values:\n\nFor participants with history of coronary artery disease: \\<100 mg/dL;\n\nfor participants with at least 3 cardiovascular (CV) risk factors: \\<120 mg/dL;\n\nfor participants with 1-2 CV risk factors: \\<140 mg/dL;\n\nfor participants with no CV risk factors: \\<160 mg/dL.'}, {'measure': 'Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)', 'timeFrame': 'End of Week 4 to Week 16 or discontinuation', 'description': 'Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.'}, {'measure': 'Percent Change in Total Lipids and Hs-CRP', 'timeFrame': 'End of washout to Week 16 or discontinuation', 'description': 'Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '24653510', 'type': 'RESULT', 'citation': 'Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C \\<160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C \\<140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C \\<120 mg/dL; and for participants with history of coronary artery disease - LDL-C \\<100 mg/dL.\n* outpatient men or women, age 20 years and older\n\nExclusion Criteria:\n\n* fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.\n* homozygous familial hypercholesterolemia.\n* creatine phosphokinase (CPK) \\>2 times the upper limit of normal (X ULN) at start of washout or treatment period.\n* glycosylated hemoglobin (HbA1c) \\>=8％ at start of washout or treatment period.\n* severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2X ULN at start of washout or treatment period.\n* hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.\n* pregnant or lactating\n* discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)\n* cyclosporine treatment\n* hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.\n* hyperlipidemia associated with drug administration that causes adverse serum lipid effects.\n* participation in a clinical study within 4 weeks of washout\n* cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.'}, 'identificationModule': {'nctId': 'NCT00871351', 'briefTitle': 'Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'P06027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe + Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg', 'interventionNames': ['Drug: Ezetimibe', 'Drug: Atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Ezetimibe', 'type': 'DRUG', 'otherNames': ['SCH 058235'], 'description': '1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)', 'armGroupLabels': ['Ezetimibe + Atorvastatin']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': '1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)', 'armGroupLabels': ['Ezetimibe + Atorvastatin']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': '2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)', 'armGroupLabels': ['Atorvastatin']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': '1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)', 'armGroupLabels': ['Rosuvastatin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}