Viewing Study NCT00535405

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Ignite Creation Date: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2026-03-02 @ 8:40 PM
Study NCT ID: NCT00535405
Status: COMPLETED
Last Update Posted: 2024-05-16
First Post: 2007-09-25
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Bulgaria', 'Chile', 'Colombia', 'Costa Rica', 'Croatia', 'Denmark', 'Finland', 'Germany', 'Ireland', 'Italy', 'Lithuania', 'Norway', 'Peru', 'Poland', 'Puerto Rico', 'Russia', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, '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}}, 'adverseEventsModule': {'description': 'AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).', 'eventGroups': [{'id': 'EG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks', 'otherNumAtRisk': 257, 'otherNumAffected': 26, 'seriousNumAtRisk': 257, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks', 'otherNumAtRisk': 256, 'otherNumAffected': 32, 'seriousNumAtRisk': 256, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks', 'otherNumAtRisk': 258, 'otherNumAffected': 26, 'seriousNumAtRisk': 258, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks', 'otherNumAtRisk': 257, 'otherNumAffected': 32, 'seriousNumAtRisk': 257, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Atorvastatin 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks', 'otherNumAtRisk': 256, 'otherNumAffected': 30, 'seriousNumAtRisk': 256, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'AV dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal strangulated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical complication of implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pickwickian syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '236', 'groupId': 'OG003'}, {'value': '239', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.5', 'groupId': 'OG000', 'lowerLimit': '-41.4', 'upperLimit': '-37.5'}, {'value': '-54.2', 'groupId': 'OG001', 'lowerLimit': '-56.1', 'upperLimit': '-52.2'}, {'value': '-46.6', 'groupId': 'OG002', 'lowerLimit': '-48.6', 'upperLimit': '-44.7'}, {'value': '-59.1', 'groupId': 'OG003', 'lowerLimit': '-61.0', 'upperLimit': '-57.1'}, {'value': '-50.8', 'groupId': 'OG004', 'lowerLimit': '-52.8', 'upperLimit': '-48.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-14.7', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '-12.0', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '-4.8', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.2', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '-5.5', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'Percent change in LDL-C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '236', 'groupId': 'OG003'}, {'value': '239', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '2.85', 'groupId': 'OG002'}, {'value': '68.2', 'spread': '3.03', 'groupId': 'OG003'}, {'value': '38.1', 'spread': '3.14', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '12.62', 'ciLowerLimit': '7.64', 'ciUpperLimit': '20.83', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.23', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.\n\nGeneralized Estimating Equations (GEE)'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '3.83', 'ciLowerLimit': '2.51', 'ciUpperLimit': '5.85', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.83', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '3.66', 'ciLowerLimit': '2.39', 'ciUpperLimit': '5.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.79', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'Percent of Patients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '236', 'groupId': 'OG003'}, {'value': '239', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '61.3', 'spread': '3.16', 'groupId': 'OG002'}, {'value': '82.1', 'spread': '2.50', 'groupId': 'OG003'}, {'value': '69.9', 'spread': '2.97', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '3.05', 'ciLowerLimit': '2.04', 'ciUpperLimit': '4.55', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.32', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '0.023', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.87', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Patients with AVD Who Achieved LDL-C \\<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.', 'unitOfMeasure': 'Percent of Patients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '236', 'groupId': 'OG003'}, {'value': '239', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '83.6', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '76.9', 'spread': '2.73', 'groupId': 'OG002'}, {'value': '90.3', 'spread': '1.93', 'groupId': 'OG003'}, {'value': '79.5', 'spread': '2.61', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '4.47', 'ciLowerLimit': '2.76', 'ciUpperLimit': '7.24', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.10', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '0.026', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '1.07', 'ciUpperLimit': '2.94', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '0.017', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '2.27', 'ciLowerLimit': '1.23', 'ciUpperLimit': '4.18', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.71', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Percent of Patients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '4.24', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '4.01', 'groupId': 'OG002'}, {'value': '69.2', 'spread': '4.05', 'groupId': 'OG003'}, {'value': '38.2', 'spread': '4.17', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '7.60', 'ciLowerLimit': '4.31', 'ciUpperLimit': '13.42', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.20', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '1.86', 'ciUpperLimit': '4.67', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.42', 'ciUpperLimit': '3.27', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.', 'unitOfMeasure': 'Percent of Patients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '5.52', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '5.23', 'groupId': 'OG002'}, {'value': '65.8', 'spread': '5.34', 'groupId': 'OG003'}, {'value': '44.4', 'spread': '5.86', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '6.02', 'ciLowerLimit': '2.71', 'ciUpperLimit': '13.38', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.45', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '0.069', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of odds', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.96', 'ciUpperLimit': '2.60', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}, {'pValue': '0.039', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of odds', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.90', 'pValueComment': 'Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva', 'statisticalMethod': 'Logistic Regression using GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Patients with AVD Who Achieved LDL-C \\<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.', 'unitOfMeasure': 'Percent of Patients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-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 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'FG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'FG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'FG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '259'}, {'groupId': 'FG002', 'numSubjects': '259'}, {'groupId': 'FG003', 'numSubjects': '257'}, {'groupId': 'FG004', 'numSubjects': '257'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '241'}, {'groupId': 'FG003', 'numSubjects': '235'}, {'groupId': 'FG004', 'numSubjects': '241'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Phase III\n\nFirst Patient In 08-Nov-2007; Last Patient Last Visit 23-Mar-2009\n\nEligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease 65 years and older.', 'preAssignmentDetails': 'The study evaluated patients ≥ 65 years of age at moderately high or high risk for Coronary Heart Disease (CHD), with or without atherosclerotic vascular disease. The study was a 3-week single-blind placebo run-in period and a 12-week active treatment period where patients were equally randomized to one of 5 treatment groups for 12 weeks'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}, {'value': '257', 'groupId': 'BG004'}, {'value': '1289', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Atorvastatin 10 mg', 'description': 'Atorvastatin (Atorva) 10 mg once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Ezetimibe 10 mg/Simvastatin 20 mg', 'description': 'Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Atorvastatin 20 mg', 'description': 'Atorvastatin 20 mg once daily for 12 weeks'}, {'id': 'BG003', 'title': 'Ezetimibe 10 mg/Simvastatin 40 mg', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks'}, {'id': 'BG004', 'title': 'Atorva 40 mg', 'description': 'Atorvastatin 40 mg once daily for 12 weeks'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '94'}, {'value': '71.8', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '95'}, {'value': '71.7', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '90'}, {'value': '72.2', 'groupId': 'BG003', 'lowerLimit': '65', 'upperLimit': '96'}, {'value': '72.1', 'groupId': 'BG004', 'lowerLimit': '65', 'upperLimit': '88'}, {'value': '72.0', 'groupId': 'BG005', 'lowerLimit': '65', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}, {'value': '163', 'groupId': 'BG004'}, {'value': '809', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '480', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '135', 'groupId': 'BG005'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}, {'value': '1081', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2007-09-25', 'resultsFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-04-26', 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12', 'timeFrame': 'Baseline and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12', 'timeFrame': '12 Weeks', 'description': 'Patients with AVD Who Achieved LDL-C \\<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.'}, {'measure': 'Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12', 'timeFrame': '12 Weeks'}, {'measure': 'Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12', 'timeFrame': '12 Weeks', 'description': 'Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.'}, {'measure': 'Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12', 'timeFrame': '12 Weeks', 'description': 'Patients with AVD Who Achieved LDL-C \\<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.'}]}, 'conditionsModule': {'keywords': ['High Cholesterol'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '21029821', 'type': 'RESULT', 'citation': 'Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a cholesterol level of 130 mg/dL or greater\n* Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study\n* Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines\n\nExclusion Criteria:\n\n* Patient weighs less than 100 lbs\n* Patient has an allergy to ezetimibe, simvastatin or atorvastatin'}, 'identificationModule': {'nctId': 'NCT00535405', 'briefTitle': 'A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease', 'orgStudyIdInfo': {'id': '0653A-128'}, 'secondaryIdInfos': [{'id': '2007_588'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Each patient will receive 1 active treatment dose \\& 2 Placebo (Pbo) doses or 2 active treatment doses \\& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.', 'interventionNames': ['Drug: Atorvastatin 10 mg']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Each patient will receive 1 active treatment dose \\& 2 Pbo doses or 2 active treatment doses \\& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.', 'interventionNames': ['Drug: Ezetimibe 10 mg/simvastatin 20 mg']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Each patient will receive 1 active treatment dose \\& 2 Pbo doses or 2 active treatment doses \\& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.', 'interventionNames': ['Drug: Atorvastatin 20 mg']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Each patient will receive 1 active treatment dose \\& 2 Pbo doses or 2 active treatment doses \\& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.', 'interventionNames': ['Drug: Ezetimibe 10 mg/simvastatin 40 mg']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Each patient will receive 1 active treatment dose \\& 2 Pbo doses or 2 active treatment doses \\& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.', 'interventionNames': ['Drug: Atorvastatin 40 mg']}], 'interventions': [{'name': 'Atorvastatin 10 mg', 'type': 'DRUG', 'description': 'Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'Ezetimibe 10 mg/simvastatin 20 mg', 'type': 'DRUG', 'description': 'Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'Atorvastatin 20 mg', 'type': 'DRUG', 'description': 'Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks', 'armGroupLabels': ['3']}, {'name': 'Ezetimibe 10 mg/simvastatin 40 mg', 'type': 'DRUG', 'description': 'Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks', 'armGroupLabels': ['4']}, {'name': 'Atorvastatin 40 mg', 'type': 'DRUG', 'description': 'Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Shering-Plough JV Study', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}