Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 1:59 AM
Study NCT ID:
NCT03337308
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@esperion.com', 'phone': '1-833-377-7633', 'title': 'Medical Director', 'organization': 'Esperion Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.'}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 14 weeks', 'description': 'Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened after the first dose of investigational medicinal product (IMP). The analysis was performed using the Safety Analysis Set which consists of all randomized participants who received at least 1 dose of blinded IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 26, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 27, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 26, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 12, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary vascular graft stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.2', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-17.2', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-23.2', 'spread': '2.18', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '3.49', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of Least Squares (LS) means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.0', 'ciLowerLimit': '-46.5', 'ciUpperLimit': '-29.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.32', 'estimateComment': 'Standard Error of the Difference of Least Squares (LS) Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.0', 'ciLowerLimit': '-26.1', 'ciUpperLimit': '-11.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.60', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '-6.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.37', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\\[LDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), also known as the intention-to-treat set, was defined as all randomized participants. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.1', 'groupId': 'OG000', 'lowerLimit': '-56.5', 'upperLimit': '-2.3'}, {'value': '-31.9', 'groupId': 'OG001', 'lowerLimit': '-62.6', 'upperLimit': '7.7'}, {'value': '-8.2', 'groupId': 'OG002', 'lowerLimit': '-34.4', 'upperLimit': '32.0'}, {'value': '21.6', 'groupId': 'OG003', 'lowerLimit': '-18.5', 'upperLimit': '68.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-46.1', 'ciLowerLimit': '-78.75', 'ciUpperLimit': '-15.78', 'pValueComment': 'using alpha = 0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.22', 'estimateComment': 'Standard Error of the Hodges-Lehmann Median Difference', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-25.6', 'ciLowerLimit': '-45.00', 'ciUpperLimit': '-7.15', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.14', 'estimateComment': 'Standard Error of the Hodges-Lehmann Median Difference', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-2.6', 'ciLowerLimit': '-21.35', 'ciUpperLimit': '16.25', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.08', 'estimateComment': 'Standard Error of the Hodges-Lehmann Median Difference', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: (\\[hsCRP value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice;therefore, analysis was completed with all efficacy data from these sites removed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.9', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-14.1', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '-19.9', 'spread': '2.05', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '3.28', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-33.7', 'ciLowerLimit': '-43.9', 'ciUpperLimit': '-23.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.97', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'using alpha = 0.01'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-17.8', 'ciLowerLimit': '-25.1', 'ciUpperLimit': '-10.5', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.12', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-12.1', 'ciLowerLimit': '-19.1', 'ciUpperLimit': '-5.0', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.03', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: (\\[non-HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.4', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '-16.0', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '2.46', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-27.1', 'ciLowerLimit': '-35.1', 'ciUpperLimit': '-19.1', 'pValueComment': 'using alpha = 0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.11', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-14.2', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '-8.1', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.64', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-10.4', 'ciLowerLimit': '-16.1', 'ciUpperLimit': '-4.6', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.48', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: (\\[TC value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.6', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '-15.3', 'spread': '1.97', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '2.97', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-30.1', 'ciLowerLimit': '-39.9', 'ciUpperLimit': '-20.3', 'pValueComment': 'using alpha = 0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.81', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-12.8', 'ciLowerLimit': '-20.3', 'ciUpperLimit': '-5.3', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.23', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '-9.3', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-2.1', 'pValueComment': 'using alpha = 0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.09', 'estimateComment': 'Standard Error of the Difference of LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: (\\[apo B value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.59', 'spread': '12.269', 'groupId': 'OG000'}, {'value': '-5.40', 'spread': '14.688', 'groupId': 'OG001'}, {'value': '-2.11', 'spread': '11.590', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '12.799', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\\[HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Triglycerides (TGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.90', 'spread': '25.633', 'groupId': 'OG000'}, {'value': '7.94', 'spread': '42.312', 'groupId': 'OG001'}, {'value': '-2.46', 'spread': '33.402', 'groupId': 'OG002'}, {'value': '5.47', 'spread': '31.992', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\\[TGs value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'FG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '109'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '382', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC', 'description': 'Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Bempedoic Acid 180 mg', 'description': 'Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Ezetimibe 10 mg', 'description': 'Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received placebo to match the bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '382', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '63.0', 'spread': '9.97', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '9.54', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '8.91', 'groupId': 'BG002'}, {'value': '65.6', 'spread': '10.74', 'groupId': 'BG003'}, {'value': '64.4', 'spread': '9.68', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '382', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '382', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '265', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '382', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '314', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '301', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '153.80', 'spread': '40.526', 'groupId': 'BG000'}, {'value': '145.13', 'spread': '38.456', 'groupId': 'BG001'}, {'value': '148.80', 'spread': '41.839', 'groupId': 'BG002'}, {'value': '152.80', 'spread': '46.773', 'groupId': 'BG003'}, {'value': '149.70', 'spread': '41.162', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit \\[Visit S1\\]) and predose Day 1/Week 0 (Treatment Visit 1 \\[Visit T1\\]).', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.'}, {'title': 'Non-high-density lipoprotein cholesterol (non-HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '301', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '188.22', 'spread': '46.657', 'groupId': 'BG000'}, {'value': '175.67', 'spread': '40.474', 'groupId': 'BG001'}, {'value': '180.18', 'spread': '47.308', 'groupId': 'BG002'}, {'value': '180.91', 'spread': '49.720', 'groupId': 'BG003'}, {'value': '181.26', 'spread': '45.595', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit \\[Visit S1\\]) and predose Day 1/Week 0 (Treatment Visit 1 \\[Visit T1\\]).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.'}, {'title': 'Total cholesterol (TC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '301', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '237.32', 'spread': '48.694', 'groupId': 'BG000'}, {'value': '225.55', 'spread': '43.165', 'groupId': 'BG001'}, {'value': '231.41', 'spread': '50.478', 'groupId': 'BG002'}, {'value': '231.27', 'spread': '50.210', 'groupId': 'BG003'}, {'value': '231.36', 'spread': '47.857', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit \\[Visit S1\\]) and predose Day 1/Week 0 (Treatment Visit 1 \\[Visit T1\\]).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.'}, {'title': 'Apolipoprotein B (apo B)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '289', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '121.1', 'spread': '30.85', 'groupId': 'BG000'}, {'value': '113.4', 'spread': '26.43', 'groupId': 'BG001'}, {'value': '115.5', 'spread': '31.30', 'groupId': 'BG002'}, {'value': '115.1', 'spread': '32.52', 'groupId': 'BG003'}, {'value': '116.4', 'spread': '29.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the predose Day 1/Week 0 (Visit T1) value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. Only participants with available data were analyzed.'}, {'title': 'High-sensitivity C-reactive protein (hsCRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '296', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.08', 'groupId': 'BG000', 'lowerLimit': '1.68', 'upperLimit': '6.20'}, {'value': '2.91', 'groupId': 'BG001', 'lowerLimit': '1.40', 'upperLimit': '5.04'}, {'value': '2.78', 'groupId': 'BG002', 'lowerLimit': '1.30', 'upperLimit': '5.89'}, {'value': '3.01', 'groupId': 'BG003', 'lowerLimit': '1.26', 'upperLimit': '5.51'}, {'value': '2.96', 'groupId': 'BG004', 'lowerLimit': '1.40', 'upperLimit': '5.78'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline was defined as the predose Day 1/Week 0 (Visit T1) value.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. Only participants with available data were analyzed.'}, {'title': 'Triglycerides (TGs)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '301', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '177.19', 'spread': '94.904', 'groupId': 'BG000'}, {'value': '156.65', 'spread': '71.985', 'groupId': 'BG001'}, {'value': '161.73', 'spread': '79.924', 'groupId': 'BG002'}, {'value': '144.59', 'spread': '55.814', 'groupId': 'BG003'}, {'value': '162.33', 'spread': '79.973', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit \\[Visit S1\\]) and predose Day 1/Week 0 (Treatment Visit 1 \\[Visit T1\\]).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.'}, {'title': 'High-density lipoprotein cholesterol (HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '301', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '49.19', 'spread': '14.566', 'groupId': 'BG000'}, {'value': '49.89', 'spread': '12.383', 'groupId': 'BG001'}, {'value': '51.23', 'spread': '15.902', 'groupId': 'BG002'}, {'value': '50.40', 'spread': '14.067', 'groupId': 'BG003'}, {'value': '50.14', 'spread': '14.256', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit \\[Visit S1\\]) and predose Day 1/Week 0 (Treatment Visit 1 \\[Visit T1\\]).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.'}], 'populationDescription': 'Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-18', 'size': 844718, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-17T09:53', 'hasProtocol': True}, {'date': '2018-06-08', 'size': 440610, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-17T09:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2018-09-21', 'completionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2017-11-06', 'dispFirstSubmitQcDate': '2018-09-21', 'resultsFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2017-11-06', 'dispFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-25', 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\\[LDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: (\\[hsCRP value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.'}, {'measure': 'Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: (\\[non-HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.'}, {'measure': 'Percent Change From Baseline to Week 12 in Total Cholesterol (TC)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: (\\[TC value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.'}, {'measure': 'Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: (\\[apo B value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.'}, {'measure': 'Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\\[HDL-C value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.'}, {'measure': 'Percent Change From Baseline to Week 12 in Triglycerides (TGs)', 'timeFrame': 'Baseline; Week 12', 'description': 'Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\\[TGs value at Week 12 minus Baseline value\\] divided by \\[Baseline Value\\]) multiplied by 100.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperlipidemia', 'heterozygous familial hypercholesterolemia', 'atherosclerotic cardiovascular disease', 'high cholesterol', 'ASCVD', 'HeFH', 'LDL'], 'conditions': ['Hyperlipidemias']}, 'referencesModule': {'references': [{'pmid': '27892461', 'type': 'BACKGROUND', 'citation': 'Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.'}, {'pmid': '21067804', 'type': 'BACKGROUND', 'citation': "Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8."}, {'pmid': '27594540', 'type': 'BACKGROUND', 'citation': 'Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.'}, {'pmid': '27673306', 'type': 'BACKGROUND', 'citation': 'Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985.'}, {'pmid': '24222016', 'type': 'BACKGROUND', 'citation': 'Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.'}, {'pmid': '31357887', 'type': 'DERIVED', 'citation': 'Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease\n* Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)\n* Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Total Fasting Triglyceride ≥ 400 mg/dL\n* Renal Dysfunction or nephrotic syndrome or history of nephritis\n* Significant cardiovascular disease or cardiovascular event within the past 3 months'}, 'identificationModule': {'nctId': 'NCT03337308', 'briefTitle': 'A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy', 'orgStudyIdInfo': {'id': '1002FDC-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BA 180 mg + EZE 10 mg FDC', 'description': 'Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks', 'interventionNames': ['Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'BA 180 mg', 'description': 'Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks', 'interventionNames': ['Drug: Bempedoic Acid', 'Drug: Placebos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EZE 10 mg', 'description': 'Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks', 'interventionNames': ['Drug: Ezetimibe', 'Drug: Placebos']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebos', 'description': 'Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Bempedoic Acid + Ezetimibe Fixed-Dose Combination', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Bempedoic Acid + Zetia FDC', 'ETC-1002 + Zetia'], 'description': 'bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet', 'armGroupLabels': ['BA 180 mg + EZE 10 mg FDC']}, {'name': 'Bempedoic Acid', 'type': 'DRUG', 'otherNames': ['ETC-1002'], 'description': 'bempedoic acid 180 mg tablet', 'armGroupLabels': ['BA 180 mg']}, {'name': 'Ezetimibe', 'type': 'DRUG', 'otherNames': ['Zetia'], 'description': 'ezetimibe 10 mg overencapsulated tablet', 'armGroupLabels': ['EZE 10 mg']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule', 'armGroupLabels': ['BA 180 mg', 'BA 180 mg + EZE 10 mg FDC', 'EZE 10 mg', 'Placebos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'PMG Research of McFarland', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '03060', 'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Foundation Cardiology', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '28625', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Piedmont Healthcare', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '37912', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'PMG Research of Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Ron Haberman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Esperion Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}