Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT00418834
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2007-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', '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': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy', 'eventGroups': [{'id': 'EG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks', 'otherNumAffected': 46, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks', 'otherNumAffected': 54, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asparate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain stem haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 525, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.7', 'groupId': 'OG000', 'lowerLimit': '-28.6', 'upperLimit': '-24.7'}, {'value': '-12.8', 'groupId': 'OG001', 'lowerLimit': '-14.8', 'upperLimit': '-10.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-13.8', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '-11.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population\n\nincludes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at\n\nleast one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication\n\nwere included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.5', 'groupId': 'OG000', 'lowerLimit': '-25.0', 'upperLimit': '-19.9'}, {'value': '-17.9', 'groupId': 'OG001', 'lowerLimit': '-20.5', 'upperLimit': '-15.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '-1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS\n\npopulation includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)\n\nvalue and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind\n\nstudy medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'title': '<70 mg/dL', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': '≥70 mg/dL', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '6.32', 'ciLowerLimit': '4.52', 'ciUpperLimit': '8.84', 'estimateComment': 'Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C, and AVD status'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population\n\nincludes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at\n\nleast one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication\n\nwere included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'title': '<70 mg/dL', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}, {'title': '≥70 mg/dL', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '1.40', 'ciUpperLimit': '2.50', 'estimateComment': 'Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C, and AVD status'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS\n\npopulation includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)\n\nvalue and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind\n\nstudy medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'title': '<100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD)', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': '>100 mg/dL (w/o AVD) and ≥70 mg/dL (w/AVD)', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.48', 'ciLowerLimit': '3.98', 'ciUpperLimit': '7.55', 'estimateComment': 'Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C, and AVD status'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', '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.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'title': '<100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD)', 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': '≥100 mg/dL (w/o AVD) and ≥70 mg/dL (w/ AVD)', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.31', 'estimateComment': 'Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C, and AVD status'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.0'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '2.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '0.3', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.8'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '0.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '1.5', 'ciUpperLimit': '4.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.5', 'groupId': 'OG000', 'lowerLimit': '-25.2', 'upperLimit': '-21.7'}, {'value': '-11.2', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '-9.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-14.2', 'ciUpperLimit': '-10.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline non-HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.0', 'groupId': 'OG000', 'lowerLimit': '-22.3', 'upperLimit': '-17.7'}, {'value': '-15.8', 'groupId': 'OG001', 'lowerLimit': '-18.1', 'upperLimit': '-13.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline non-HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseine and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.9', 'groupId': 'OG000', 'lowerLimit': '-17.2', 'upperLimit': '-14.6'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-9.3', 'upperLimit': '-6.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '-6.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Total Cholesterol, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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)\n\nvalue 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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.6', 'groupId': 'OG000', 'lowerLimit': '-15.2', 'upperLimit': '-12.0'}, {'value': '-11.6', 'groupId': 'OG001', 'lowerLimit': '-13.2', 'upperLimit': '-10.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Total Cholesterol, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Triglycerides (TG) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.9', 'groupId': 'OG000', 'lowerLimit': '-14.3', 'upperLimit': '-9.7'}, {'value': '-5.7', 'groupId': 'OG001', 'lowerLimit': '-8.4', 'upperLimit': '-3.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '-3.4', 'estimateComment': "(Atorva 10 mg + EZ minus Atorva 20 mg)\n\nThe 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", 'statisticalMethod': 'Nonparametric ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Triglycerides (TG) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.8', 'groupId': 'OG000', 'lowerLimit': '-13.7', 'upperLimit': '-9.3'}, {'value': '-8.5', 'groupId': 'OG001', 'lowerLimit': '-11.3', 'upperLimit': '-7.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.0', 'estimateComment': "(Atorva 10 mg + EZ minus Atorva 20 mg)\n\nThe median difference is based on the Hodges-Lehmann estimates\n\nof shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic", 'statisticalMethod': 'Nonparametric ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}, {'value': '514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.8', 'groupId': 'OG000', 'lowerLimit': '-18.5', 'upperLimit': '-15.1'}, {'value': '-7.7', 'groupId': 'OG001', 'lowerLimit': '-9.4', 'upperLimit': '-6.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-9.1', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '-7.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Apo B, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.0', 'groupId': 'OG000', 'lowerLimit': '-16.1', 'upperLimit': '-11.9'}, {'value': '-10.8', 'groupId': 'OG001', 'lowerLimit': '-12.9', 'upperLimit': '-8.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Apo B, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}, {'value': '514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '0.3'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-0.3'}]}]}], 'analyses': [{'pValue': '0.401', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Apo A-I, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '2.1'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '-0.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '1.1', 'ciUpperLimit': '4.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Apo A-I, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.9', 'groupId': 'OG000', 'lowerLimit': '-18.4', 'upperLimit': '-15.3'}, {'value': '-7.9', 'groupId': 'OG001', 'lowerLimit': '-9.4', 'upperLimit': '-6.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-9.0', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '-7.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Total-C:HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.4', 'groupId': 'OG000', 'lowerLimit': '-16.4', 'upperLimit': '-12.5'}, {'value': '-9.8', 'groupId': 'OG001', 'lowerLimit': '-11.8', 'upperLimit': '-7.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '-2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Total-C:HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', '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': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.2', 'groupId': 'OG000', 'lowerLimit': '-29.5', 'upperLimit': '-25.0'}, {'value': '-12.6', 'groupId': 'OG001', 'lowerLimit': '-14.9', 'upperLimit': '-10.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-14.6', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '-12.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C:HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.9', 'groupId': 'OG000', 'lowerLimit': '-25.9', 'upperLimit': '-20.0'}, {'value': '-16.0', 'groupId': 'OG001', 'lowerLimit': '-18.9', 'upperLimit': '-13.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-6.9', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '-3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline LDL-C:HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}, {'value': '514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.8', 'groupId': 'OG000', 'lowerLimit': '-16.6', 'upperLimit': '-12.9'}, {'value': '-5.2', 'groupId': 'OG001', 'lowerLimit': '-7.1', 'upperLimit': '-3.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '-7.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Apo B:Apo A-I, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.5', 'groupId': 'OG000', 'lowerLimit': '-15.7', 'upperLimit': '-11.3'}, {'value': '-8.2', 'groupId': 'OG001', 'lowerLimit': '-10.4', 'upperLimit': '-6.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '-2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline Apo B:Apo A-I, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.0', 'groupId': 'OG000', 'lowerLimit': '-26.2', 'upperLimit': '-21.8'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-13.3', 'upperLimit': '-8.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-12.9', 'ciLowerLimit': '-15.3', 'ciUpperLimit': '-10.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.4', 'groupId': 'OG000', 'lowerLimit': '-23.2', 'upperLimit': '-17.6'}, {'value': '-13.8', 'groupId': 'OG001', 'lowerLimit': '-16.6', 'upperLimit': '-10.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '-3.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.5', 'groupId': 'OG000', 'lowerLimit': '-19.6', 'upperLimit': '-6.8'}, {'value': '-10.7', 'groupId': 'OG001', 'lowerLimit': '-17.0', 'upperLimit': '-3.9'}]}]}], 'analyses': [{'pValue': '0.534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-11.9', 'ciUpperLimit': '6.4', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg)\n\nData 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.', 'statisticalMethod': 'Longitudinal Data Analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'unitOfMeasure': 'Percent Change', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.7', 'groupId': 'OG000', 'lowerLimit': '-27.3', 'upperLimit': '-15.6'}, {'value': '-14.6', 'groupId': 'OG001', 'lowerLimit': '-20.7', 'upperLimit': '-8.0'}]}]}], 'analyses': [{'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '1.6', 'estimateComment': '(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)\n\nData 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.', 'statisticalMethod': 'Longitudinal Data Analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Percent Change', '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}, {'groupId': 'FG001', 'numSubjects': '527'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '503'}, {'groupId': 'FG001', 'numSubjects': '507'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Phase III\n\nFirst Patient In: 28-Feb-2007; Last Patient Last Visit: 01-Oct-2008\n\n143 centers worldwide (United States, Canada, Poland, Romania, Ukraine and Russia)', 'preAssignmentDetails': 'Patients were stratified based on baseline LDL-C levels and presence or absence of atherosclerotic vascular\n\ndisease to achieve balance across treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1053', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atorva 10 mg + EZ', 'description': '\\[Atorva 10 mg + Ezetimibe 10 mg\\] orally once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Atorva 20 mg / Atorva 40 mg', 'description': 'Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '71.2', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '92'}, {'value': '71.2', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '490', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '503', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1008', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '667', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'BMI [Body Mass Index (<30, ≥30 kg/m2)]', 'classes': [{'title': '<30 kg/m2', 'categories': [{'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}]}, {'title': '≥30 kg/m2', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Apo lipoprotein A-I (Apo A-I)', 'classes': [{'categories': [{'measurements': [{'value': '164.3', 'spread': '28.7', 'groupId': 'BG000'}, {'value': '164.4', 'spread': '26.8', 'groupId': 'BG001'}, {'value': '164.4', 'spread': '27.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apo lipoprotein B (Apo B)', 'classes': [{'categories': [{'measurements': [{'value': '103.6', 'spread': '22.8', 'groupId': 'BG000'}, {'value': '101.8', 'spread': '21.4', 'groupId': 'BG001'}, {'value': '102.7', 'spread': '22.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apo lipoprotein B (Apo B):Apo lipoprotein A-I (Apo A-I) Ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein Cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Highly selective C-reactive protein (hs-CRP)', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Robust Standard Deviation was calculated for hs-CRP as: interquartile range\n\n(IQR)/1.075, where IQR=3rd quartile - 1st quartile.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low Density Lipoprotein Cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '102.9', 'spread': '27.7', 'groupId': 'BG000'}, {'value': '101.8', 'spread': '20.7', 'groupId': 'BG001'}, {'value': '102.3', 'spread': '24.4', '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': '2.0', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '2.0', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-High Density Lipoprotein Cholesterol (Non-HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '128.2', 'spread': '30.6', 'groupId': 'BG000'}, {'value': '127.2', 'spread': '25.2', 'groupId': 'BG001'}, {'value': '127.7', 'spread': '28.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-High Density Lipoprotein Cholesterol (Non-HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ra', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '183.1', 'spread': '31.8', 'groupId': 'BG000'}, {'value': '181.8', 'spread': '26.1', 'groupId': 'BG001'}, {'value': '182.4', 'spread': '29.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol (TC):High Density Lipoprotein-C (HDL-C) Ratio', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (TG)', 'classes': [{'categories': [{'measurements': [{'value': '112.8', 'spread': '55.3', 'groupId': 'BG000'}, {'value': '116.5', 'spread': '60.0', 'groupId': 'BG001'}, {'value': '114.0', 'spread': '56.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Robust Standard Deviation was calculated for Triglycerides as: interquartile range (IQR)/1.075, where IQR=3rd quartile - 1st quartile.', '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': 1053}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2007-01-03', 'resultsFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2007-01-04', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-08-31', 'studyFirstPostDateStruct': {'date': '2007-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12', 'timeFrame': 'Baseine and Week 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Triglycerides (TG) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Triglycerides (TG) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12', 'timeFrame': 'Baseline and Week 12'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C at Week 6', 'timeFrame': 'Baseline and Week 6'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6', 'timeFrame': 'Week 6'}, {'measure': 'Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12', 'timeFrame': 'Week 12'}, {'measure': 'Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6', 'timeFrame': 'Week 6'}, {'measure': 'Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12', 'timeFrame': 'Week 12'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '20185012', 'type': 'RESULT', 'citation': 'Zieve F, Wenger NK, Ben-Yehuda O, Constance C, Bird S, Lee R, Hanson ME, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe added to atorvastatin versus up titration of atorvastatin to 40 mg in Patients > or = 65 years of age (from the ZETia in the ELDerly [ZETELD] study). Am J Cardiol. 2010 Mar 1;105(5):656-63. doi: 10.1016/j.amjcard.2009.10.029. Epub 2009 Dec 24.'}, {'pmid': '24411003', 'type': 'DERIVED', 'citation': 'Constance C, Ben-Yehuda O, Wenger NK, Zieve F, Lin J, Hanson ME, Lowe RS, Tershakovec AM. Atorvastatin 10 mg plus ezetimibe versus titration to atorvastatin 40 mg: attainment of European and Canadian guideline lipid targets in high-risk subjects >/=65 years. Lipids Health Dis. 2014 Jan 13;13:13. doi: 10.1186/1476-511X-13-13.'}]}, 'descriptionModule': {'briefSummary': 'A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is age 65 or older\n* Patient is willing to maintain cholesterol lowering diet\n* Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category\n\nExclusion Criteria:\n\n* A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study\n* Patient is unlikely to be compliant in taking study medication\n* Patient with chronic or unstable medical condition\n* Patient is taking unstable doses of medication\n* Patient drinks more than 2 alcoholic drinks per day\n* Patient has elevations in certain laboratory values (CK, AST, ALT)'}, 'identificationModule': {'nctId': 'NCT00418834', 'briefTitle': 'Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD', 'orgStudyIdInfo': {'id': '0653-112'}, 'secondaryIdInfos': [{'id': 'MK0653-112'}, {'id': '2006_549'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: ezetimibe and atorvastatin', 'Drug: Placebo (unspecified)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: atorvastatin', 'Drug: Placebo (unspecified)']}], 'interventions': [{'name': 'ezetimibe and atorvastatin', 'type': 'DRUG', 'description': 'ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks', 'armGroupLabels': ['2']}, {'name': 'Placebo (unspecified)', 'type': 'DRUG', 'description': 'Placebo (unspecified) daily for 12 weeks', 'armGroupLabels': ['1', '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'}}}}