Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-04 @ 3:43 PM
Study NCT ID:
NCT00639158
Status:
COMPLETED
Last Update Posted:
2011-06-13
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) 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': 'D011345', 'term': 'Fenofibrate'}, {'id': 'C006012', 'term': 'fenofibric acid'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', '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 + 40 mg Atorvastatin + 10 mg Ezetimibe', 'otherNumAtRisk': 272, 'otherNumAffected': 41, 'seriousNumAtRisk': 272, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe', 'otherNumAtRisk': 270, 'otherNumAffected': 51, 'seriousNumAtRisk': 270, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Esophageal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wound Infection Staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Percent Change in Triglycerides From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.3', 'spread': '22.32', 'groupId': 'OG000', 'lowerLimit': '-67.1', 'upperLimit': '-46.3'}, {'value': '-39.7', 'spread': '29.44', 'groupId': 'OG001', 'lowerLimit': '-52.5', 'upperLimit': '-20.9'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.', 'groupDescription': 'A sample size of 212 per arm provided 90% power and \\> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 Weeks (Final Visit)', 'description': '\\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\\] x 100', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Corresponding baseline lipid value as the covariate and with effect for treatment group.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks (Final Visit)', 'description': '\\[(Week 12 apoAI minus baseline apoAI)/baseline apoAI\\] x 100', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.', 'groupDescription': 'A sample size of 212 per arm provided 90% power and \\> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Corresponding baseline lipid value as the covariate and with effect for treatment group.', '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 high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.8', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '-41.1', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Corresponding baseline lipid value as the covariate and with effect for treatment group.', 'testedNonInferiority': False}], '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, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.5', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-25.3', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Corresponding lipid value as the covariate and with effect for treatment group.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks (Final Visit)', 'description': '\\[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII\\] x 100', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'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': '262', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.6', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-51.0', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Corresponding baseline lipid value as the covariate and with effect for treatment group.', 'testedNonInferiority': False}], '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, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.1', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-44.7', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Corresponding baseline lipid value as the covariate and with effect for treatment group.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks (Final Visit)', 'description': '\\[(Week 12 apoB minus baseline apoB)/baseline apoB\\] 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, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'OG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.1', 'spread': '102.82', 'groupId': 'OG000', 'lowerLimit': '-67.4', 'upperLimit': '-25.4'}, {'value': '-40.3', 'spread': '516.56', 'groupId': 'OG001', 'lowerLimit': '-60.6', 'upperLimit': '-13.4'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Rank-sum test', 'testedNonInferiority': False}], '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, last observation carried forward.', 'anticipatedPostingDate': '2009-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'FG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All randomized subjects were treated.', 'groupId': 'FG000', 'numSubjects': '272'}, {'comment': '1 subject was randomized but not treated because of an abnormal ECG that precluded treatment.', 'groupId': 'FG001', 'numSubjects': '270'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '26 subjects prematurely discontinued treatment.', 'groupId': 'FG000', 'numSubjects': '246'}, {'comment': '30 subjects prematurely discontinued treatment', 'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}]}], 'preAssignmentDetails': 'One subject was randomized to the atorvastatin and ezetimibe treatment group and never received study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'BG001', 'title': 'Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 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{'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 543}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-09', 'studyFirstSubmitDate': '2008-03-14', 'resultsFirstSubmitDate': '2009-10-02', 'studyFirstSubmitQcDate': '2008-03-14', 'lastUpdatePostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-02', 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median 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'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 weeks (Final Visit)', 'description': '\\[(Week 12 apoAI minus baseline apoAI)/baseline apoAI\\] 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 Apolipoprotein CIII (apoCIII) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 weeks (Final Visit)', 'description': '\\[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII\\] x 100'}, {'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 Apolipoprotein B (apoB) From Baseline to Final Visit', 'timeFrame': 'Baseline to 12 weeks (Final Visit)', 'description': '\\[(Week 12 apoB minus baseline apoB)/baseline apoB\\] 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': {'conditions': ['Dyslipidemias', 'Coronary Heart Disease', 'Combined (Atherogenic) Dyslipidemia', 'Mixed Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '20934572', 'type': 'DERIVED', 'citation': 'Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) 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 (trigylcerides, \\> or = to 150 mg/dL to \\< 400 mg/dL; HDL-C \\< 40 mg/dL for males, \\< 50 mg/dL for females; LDL-C, \\> or = to 130 mg/dL).\n* Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.\n\nExclusion Criteria:\n\n* Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.\n* Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.\n* Women who are pregnant or plan on becoming pregnant, or women who are lactating.'}, 'identificationModule': {'nctId': 'NCT00639158', 'briefTitle': 'Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) 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 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia', 'orgStudyIdInfo': {'id': 'M10-275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ABT-335 + atorvastatin + ezetimibe', 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