Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00300456
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2006-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533234', 'term': '2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'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': {'phone': '800-633-9110', 'title': 'Medical Information Specialist', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall be so restricted after the expiration of twelve (12) months from completion of the studies at all sites. Any presentation or publication to be submitted to Sponsor (in draft of the same) for Sponsor review and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily', 'otherNumAffected': 65, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily', 'otherNumAffected': 72, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily', 'otherNumAffected': 67, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily', 'otherNumAffected': 60, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily', 'otherNumAffected': 65, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily', 'otherNumAffected': 26, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypoesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pelvic prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arterial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change in Triglycerides From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.4', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-42.7', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-31.7', 'spread': '2.74', 'groupId': 'OG002'}, {'value': '-14.2', 'spread': '2.71', 'groupId': 'OG003'}, {'value': '-22.4', 'spread': '2.76', 'groupId': 'OG004'}, {'value': '-20.2', 'spread': '3.82', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses', 'groupDescription': 'An n = 92 per arm would provide \\>99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'pValueComment': 'alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses', 'groupDescription': 'An n = 92 per arm would provide \\>99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '1.85', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '1.80', 'groupId': 'OG003'}, {'value': '8.5', 'spread': '1.89', 'groupId': 'OG004'}, {'value': '6.8', 'spread': '2.61', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses', 'groupDescription': 'An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'pValueComment': 'alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses', 'groupDescription': 'An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.0', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-25.3', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '1.96', 'groupId': 'OG002'}, {'value': '-22.4', 'spread': '1.90', 'groupId': 'OG003'}, {'value': '-31.7', 'spread': '1.98', 'groupId': 'OG004'}, {'value': '-40.8', 'spread': '2.69', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses', 'groupDescription': 'An n = 92 per arm would provide \\>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses', 'groupDescription': 'An n = 92 per arm would provide \\>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.7', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-35.0', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '-17.3', 'spread': '1.46', 'groupId': 'OG002'}, {'value': '-24.4', 'spread': '1.43', 'groupId': 'OG003'}, {'value': '-35.9', 'spread': '1.49', 'groupId': 'OG004'}, {'value': '-40.6', 'spread': '2.06', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.9', 'spread': '4.06', 'groupId': 'OG000'}, {'value': '-51.1', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '-36.9', 'spread': '4.04', 'groupId': 'OG002'}, {'value': '-19.2', 'spread': '4.04', 'groupId': 'OG003'}, {'value': '-35.7', 'spread': '4.06', 'groupId': 'OG004'}, {'value': '-30.0', 'spread': '5.66', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Total Cholesterol From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.9', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-27.1', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-12.4', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '-19.8', 'spread': '1.19', 'groupId': 'OG003'}, {'value': '-30.0', 'spread': '1.21', 'groupId': 'OG004'}, {'value': '-33.6', 'spread': '1.67', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.5', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-31.2', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '-17.6', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '-22.9', 'spread': '1.45', 'groupId': 'OG003'}, {'value': '-32.7', 'spread': '1.46', 'groupId': 'OG004'}, {'value': '-38.9', 'spread': '2.05', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 Apo B minus baseline Apo B)/baseline Apo B\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF'}, {'type': 'SECONDARY', 'title': 'Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'OG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'OG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'OG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'OG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'OG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.8', 'spread': '48.27', 'groupId': 'OG000', 'lowerLimit': '-40.9', 'upperLimit': '8.2'}, {'value': '-32.1', 'spread': '48.70', 'groupId': 'OG001', 'lowerLimit': '-51.5', 'upperLimit': '9.4'}, {'value': '-15.8', 'spread': '48.01', 'groupId': 'OG002', 'lowerLimit': '-42.5', 'upperLimit': '30.9'}, {'value': '-11.4', 'spread': '48.18', 'groupId': 'OG003', 'lowerLimit': '-36.0', 'upperLimit': '21.4'}, {'value': '-14.8', 'spread': '48.25', 'groupId': 'OG004', 'lowerLimit': '-40.8', 'upperLimit': '11.2'}, {'value': '-19.8', 'spread': '67.84', 'groupId': 'OG005', 'lowerLimit': '-36.0', 'upperLimit': '22.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP\\] x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'FG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'FG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'FG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'FG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'FG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'For all arms, "started" means treated.', 'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '119'}, {'groupId': 'FG004', 'numSubjects': '116'}, {'groupId': 'FG005', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '98'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '99'}, {'groupId': 'FG005', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '11'}]}]}], 'preAssignmentDetails': 'Seven subjects were randomized but never treated: 2 were taking a prohibited concomitant medication, 1 did not meet the entry criteria for lipid levels, 1 had an abnormal baseline electrocardiogram, 1 was unable to swallow pills, and 2 withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '650', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'ABT-335 + 20 mg Simvastatin', 'description': 'ABT-335 + 20 mg simvastatin combination therapy once daily'}, {'id': 'BG001', 'title': 'ABT-335 + 40 mg Simvastatin', 'description': 'ABT-335 + 40 mg simvastatin combination therapy once daily'}, {'id': 'BG002', 'title': 'ABT-335', 'description': 'ABT-335 monotherapy once daily'}, {'id': 'BG003', 'title': '20 mg Simvastatin', 'description': '20 mg simvastatin monotherapy once daily'}, {'id': 'BG004', 'title': '40 mg Simvastatin', 'description': '40 mg simvastatin monotherapy once daily'}, {'id': 'BG005', 'title': '80 mg Simvastatin', 'description': '80 mg simvastatin monotherapy once daily'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '551', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '332', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '318', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '650', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-29', 'studyFirstSubmitDate': '2006-03-07', 'resultsFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2006-03-07', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-02-20', 'studyFirstPostDateStruct': {'date': '2006-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change in Triglycerides From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\\] x 100'}, {'measure': 'Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\\] x 100'}, {'measure': 'Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\\] x 100'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C\\] x 100'}, {'measure': 'Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\\] x 100'}, {'measure': 'Mean Percent Change in Total Cholesterol From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol\\] x 100'}, {'measure': 'Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 Apo B minus baseline Apo B)/baseline Apo B\\] x 100'}, {'measure': 'Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP\\] x 100'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'Coronary Heart Disease', 'Mixed Dyslipidemia'], 'conditions': ['Dyslipidemia', 'Coronary Heart Disease', 'Mixed Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '20573750', 'type': 'DERIVED', 'citation': 'Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. doi: 10.2337/dc10-0357. Epub 2010 Jun 23.'}, {'pmid': '20136164', 'type': 'DERIVED', 'citation': 'Jones PH, Cusi K, Davidson MH, Kelly MT, Setze CM, Thakker K, Sleep DJ, Stolzenbach JC. Efficacy and safety of fenofibric acid co-administered with low- or moderate-dose statin in patients with mixed dyslipidemia and type 2 diabetes mellitus: results of a pooled subgroup analysis from three randomized, controlled, double-blind trials. Am J Cardiovasc Drugs. 2010;10(2):73-84. doi: 10.2165/10061630-000000000-00000.'}, {'pmid': '18783301', 'type': 'DERIVED', 'citation': 'Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34. doi: 10.2165/00044011-200828100-00003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with mixed dyslipidemia\n* Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.\n\nExclusion Criteria:\n\n* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.\n* Patients who are taking certain medications or unstable dose of specific medications.\n* Women who are pregnant or plan on becoming pregnant, or women who are lactating.'}, 'identificationModule': {'nctId': 'NCT00300456', 'briefTitle': 'Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia', 'orgStudyIdInfo': {'id': 'M05-749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'ABT-335 + 20 mg simvastatin', 'interventionNames': ['Drug: ABT-335', 'Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'ABT-335 + 40 mg simvastatin', 'interventionNames': ['Drug: ABT-335', 'Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'ABT-335 monotherapy', 'interventionNames': ['Drug: ABT-335', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'description': '20 mg simvastatin monotherapy', 'interventionNames': ['Drug: Simvastatin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E', 'description': '40 mg simvastatin monotherapy', 'interventionNames': ['Drug: Simvastatin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'F', 'description': '80 mg simvastatin monotherapy', 'interventionNames': ['Drug: Simvastatin', 'Drug: Placebo']}], 'interventions': [{'name': 'ABT-335', 'type': 'DRUG', 'description': '135 mg, daily, 12 weeks', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'daily, 12 weeks, see Arm Description for dosage information', 'armGroupLabels': ['A', 'B', 'D', 'E', 'F']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily, 12 weeks, see Arm Description for placebo information', 'armGroupLabels': ['C', 'D', 'E', 'F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60064', 'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Global Medical Information', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Maureen Kelly, MD', 'oldOrganization': 'Abbott'}}}}