Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT00276458
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Canada', 'Costa Rica', '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '194 out of 196 randomized patients took at least one dose of blinded study therapy and were included in the safety analysis'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks', 'otherNumAtRisk': 96, 'otherNumAffected': 17, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks', 'otherNumAtRisk': 98, 'otherNumAffected': 22, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.8', 'groupId': 'OG000', 'lowerLimit': '-34.5', 'upperLimit': '-27.0'}, {'value': '-10.9', 'groupId': 'OG001', 'lowerLimit': '-14.7', 'upperLimit': '-7.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-19.9', 'ciLowerLimit': '-25.2', 'ciUpperLimit': '-14.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline LDL-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.2'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '3.8'}]}]}], 'analyses': [{'pValue': '0.273', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '6.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.1', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline HDL-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.7', 'groupId': 'OG000', 'lowerLimit': '-30.1', 'upperLimit': '-23.3'}, {'value': '-10.2', 'groupId': 'OG001', 'lowerLimit': '-13.6', 'upperLimit': '-6.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-16.4', 'ciLowerLimit': '-21.2', 'ciUpperLimit': '-11.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline non-HDL-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total-Cholesterol at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.7', 'groupId': 'OG000', 'lowerLimit': '-22.2', 'upperLimit': '-17.1'}, {'value': '-7.4', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '-4.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '-8.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline Total-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '(\\[6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides (TG) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.8', 'groupId': 'OG000', 'lowerLimit': '-23.7', 'upperLimit': '-11.4'}, {'value': '-5.5', 'groupId': 'OG001', 'lowerLimit': '-14.4', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.9', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '-0.4', 'pValueComment': 'ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value', 'estimateComment': "The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.\n\n(Atorva + EZ minus Atorva)", 'statisticalMethod': 'Nonparametric ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.4', 'groupId': 'OG000', 'lowerLimit': '-24.3', 'upperLimit': '-18.5'}, {'value': '-7.7', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '-4.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '-9.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.1', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline Apo B value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'POST_HOC', 'title': 'Percent Change in Apolipoprotein A-I at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '0.4'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '0.681', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '2.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline Apo A-I value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.6', 'groupId': 'OG000', 'lowerLimit': '-23.7', 'upperLimit': '-17.5'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '-4.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '-8.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.2', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline Total-C:HDL-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.9', 'groupId': 'OG000', 'lowerLimit': '-35.8', 'upperLimit': '-27.9'}, {'value': '-11.0', 'groupId': 'OG001', 'lowerLimit': '-14.9', 'upperLimit': '-7.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-20.9', 'ciLowerLimit': '-26.5', 'ciUpperLimit': '-15.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.8', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline LDL-C:HDL-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.0', 'groupId': 'OG000', 'lowerLimit': '-22.3', 'upperLimit': '-15.6'}, {'value': '-5.8', 'groupId': 'OG001', 'lowerLimit': '-9.2', 'upperLimit': '-2.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-17.9', 'ciUpperLimit': '-8.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline Apo B:Apo A-I value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.2', 'groupId': 'OG000', 'lowerLimit': '-31.4', 'upperLimit': '-23.0'}, {'value': '-9.9', 'groupId': 'OG001', 'lowerLimit': '-14.1', 'upperLimit': '-5.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-17.3', 'ciLowerLimit': '-23.2', 'ciUpperLimit': '-11.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.0', 'estimateComment': '(Atorva + EZ minus Atorva)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline non-HDL-C:HDL-C value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-23.7', 'upperLimit': '14.2'}, {'value': '-9.2', 'groupId': 'OG001', 'lowerLimit': '-25.8', 'upperLimit': '11.1'}]}]}], 'analyses': [{'pValue': '0.841', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-23.8', 'ciUpperLimit': '28.8', 'estimateComment': 'Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.\n\n(Atorva + EZ minus Atorva)', 'statisticalMethod': 'Longitudinal Data Analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'POST_HOC', 'title': 'Percent Change in C-Reactive Protein (CRP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.2', 'groupId': 'OG000', 'lowerLimit': '-25.0', 'upperLimit': '-4.0'}, {'value': '-9.1', 'groupId': 'OG001', 'lowerLimit': '-22.2', 'upperLimit': '5.3'}]}]}], 'analyses': [{'pValue': '0.839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.3', 'ciLowerLimit': '-26.1', 'ciUpperLimit': '8.3', 'estimateComment': "The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.\n\n(Atorva + EZ minus Atorva)", 'statisticalMethod': 'Nonparametric ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'classes': [{'title': '<100 mg/dL', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': '≥100 mg/dL', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '8.60', 'ciLowerLimit': '3.80', 'ciUpperLimit': '19.47', 'estimateComment': 'Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and baseline LDL-C value'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'FG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Phase III\n\nFirst Patient In: 4/5/2006; Last Patient Last Visit 1/17/2008\n\n72 centers worldwide (US, Canada, Austria, Costa Rica)\n\nEligible patients include those on a stable dose of atorvastatin 20 mg; or patients with adjusted LDL-C pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve.', 'preAssignmentDetails': 'Patients received and were blinded to atorvastatin 20 mg for a 4/5- week run-in period.\n\nPatients needed an LDL-C ≥ 100 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 40 mg or addition of ezetimibe 10 mg to their 20 mg dose of atorvastatin for a 6-week treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atorvastatin + Ezetimibe', 'description': 'Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks'}, {'id': 'BG001', 'title': 'Atorvastatin', 'description': 'Atorvastatin 40 mg Daily for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '78'}, {'value': '58.0', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '76'}, {'value': '57.2', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Apolipoprotein A-I', 'classes': [{'categories': [{'measurements': [{'value': '161.8', 'spread': '25.2', 'groupId': 'BG000'}, {'value': '163.4', 'spread': '24.6', 'groupId': 'BG001'}, {'value': '162.6', 'spread': '24.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein A-I:Apolipoprotein B ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.7', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B', 'classes': [{'categories': [{'measurements': [{'value': '122.9', 'spread': '22.4', 'groupId': 'BG000'}, {'value': '119.9', 'spread': '21.0', 'groupId': 'BG001'}, {'value': '121.4', 'spread': '21.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'C Reactive Protein', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein (HDL)', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '51.4', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low Density Lipoprotein (LDL)', 'classes': [{'categories': [{'measurements': [{'value': '119.9', 'spread': '19.4', 'groupId': 'BG000'}, {'value': '117.9', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '118.9', 'spread': '18.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) ratio', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non- High Density Lipoprotein (Non-HDL) Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '151.6', 'spread': '24.1', 'groupId': 'BG000'}, {'value': '148.4', 'spread': '21.1', 'groupId': 'BG001'}, {'value': '150.0', 'spread': '22.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NonHigh Density Lipoprotein-Cholesterol (NonHDL-C):High Density Lipoprotein-Cholesterol (HDL-C)ratio', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '202.6', 'spread': '25.2', 'groupId': 'BG000'}, {'value': '200.0', 'spread': '21.5', 'groupId': 'BG001'}, {'value': '201.3', 'spread': '23.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol:High Density Lipoprotein Cholesterol (HDL-C) ratio', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (TG)', 'classes': [{'categories': [{'measurements': [{'value': '152.5', 'spread': '68.8', 'groupId': 'BG000'}, {'value': '147.8', 'spread': '75.3', 'groupId': 'BG001'}, {'value': '149.0', 'spread': '75.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2006-01-10', 'resultsFirstSubmitDate': '2008-12-18', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-05-14', 'studyFirstPostDateStruct': {'date': '2006-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Total-Cholesterol at Week 6', 'timeFrame': '6 Weeks', 'description': '(\\[6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Triglycerides (TG) at Week 6', 'timeFrame': '6 weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6', 'timeFrame': '6 Weeks', 'description': '\\[(6 week value - baseline value)/baseline value\\]\\*100%.'}, {'measure': 'Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '19026302', 'type': 'BACKGROUND', 'citation': 'Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with LDL-C \\>100 mg/dL \\& on a stable dose of atorvastatin 20 mg\n\nExclusion Criteria:\n\n* Pregnant or lactating women or intending to become pregnant\n* Patient with sensitivity or intolerance to ezetimibe or atorvastatin\n* Patient with diabetes or coronary heart disease'}, 'identificationModule': {'nctId': 'NCT00276458', 'briefTitle': 'To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg', 'orgStudyIdInfo': {'id': '0653-079'}, 'secondaryIdInfos': [{'id': '2005_104'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).', 'interventionNames': ['Drug: Comparator: atorvastatin', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).', 'interventionNames': ['Drug: Comparator: ezetimibe', 'Drug: Comparator: Placebo.']}], 'interventions': [{'name': 'Comparator: atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: ezetimibe', 'type': 'DRUG', 'description': 'Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.', 'armGroupLabels': ['2']}, {'name': 'Comparator: Placebo.', 'type': 'DRUG', 'description': 'Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.', 'armGroupLabels': ['2']}]}, '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'}}}}