Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT01288469
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2011-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact --US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational medicianal product (IMP).', 'description': "Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose to the last dose of IMP + 70 days). Safety population: participants received at least one dose or partial dose of IMP.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Atorvastatin 80mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.', 'otherNumAtRisk': 31, 'otherNumAffected': 13, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.', 'otherNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.', 'otherNumAtRisk': 30, 'otherNumAffected': 10, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-66.2', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '-73.2', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.82', 'ciLowerLimit': '-65.62', 'ciUpperLimit': '-46.03', 'pValueComment': 'Threshold for significance ≤0.05.', 'estimateComment': 'Alirocumab vs. placebo', 'groupDescription': 'Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 8 (LOCF)', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward \\[LOCF\\] method.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-2.09', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '-2.31', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-80.7', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '-89.3', 'spread': '4.1', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'title': 'LDL-C < 100 mg/dL (2.59 mmol/L)', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'LDL-C < 70 mg/dL (1.81 mmol/L)', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '96.6', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8 (LOCF)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'title': 'Total Cholesterol (n=29, 29, 30)', 'categories': [{'measurements': [{'value': '-16.6', 'groupId': 'OG000', 'lowerLimit': '-25.1', 'upperLimit': '-3.2'}, {'value': '-40.5', 'groupId': 'OG001', 'lowerLimit': '-44.8', 'upperLimit': '-36.0'}, {'value': '-47.2', 'groupId': 'OG002', 'lowerLimit': '-51.5', 'upperLimit': '-37.8'}]}]}, {'title': 'Fasting Triglycerides (n=29, 29, 30)', 'categories': [{'measurements': [{'value': '-11.9', 'groupId': 'OG000', 'lowerLimit': '-30.4', 'upperLimit': '14.3'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-30.5', 'upperLimit': '17.4'}, {'value': '-24.7', 'groupId': 'OG002', 'lowerLimit': '-40.3', 'upperLimit': '-4.4'}]}]}, {'title': 'Non-HDL-C (n= 29, 29, 30)', 'categories': [{'measurements': [{'value': '-22.3', 'groupId': 'OG000', 'lowerLimit': '-31.4', 'upperLimit': '-3.7'}, {'value': '-58.3', 'groupId': 'OG001', 'lowerLimit': '-63.9', 'upperLimit': '-50.2'}, {'value': '-63.9', 'groupId': 'OG002', 'lowerLimit': '-73.9', 'upperLimit': '-56.1'}]}]}, {'title': 'Apo-B (n = 29, 28, 29)', 'categories': [{'measurements': [{'value': '-12.0', 'groupId': 'OG000', 'lowerLimit': '-23.6', 'upperLimit': '-3.5'}, {'value': '-54.4', 'groupId': 'OG001', 'lowerLimit': '-60.2', 'upperLimit': '-48.3'}, {'value': '-58.0', 'groupId': 'OG002', 'lowerLimit': '-67.1', 'upperLimit': '-46.1'}]}]}, {'title': 'Lipoprotein(a) (n= 29, 28, 29)', 'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-19.5', 'upperLimit': '16.7'}, {'value': '-34.7', 'groupId': 'OG001', 'lowerLimit': '-50.0', 'upperLimit': '-24.7'}, {'value': '-31.0', 'groupId': 'OG002', 'lowerLimit': '-50.0', 'upperLimit': '-15.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to Week 8 (LOCF)', 'description': 'Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the mITT population with one baseline and at least one post-baseline on treatment HDL-C value.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'OG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.08'}, {'value': '-0.34', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '-0.27'}, {'value': '-0.36', 'groupId': 'OG002', 'lowerLimit': '-0.40', 'upperLimit': '-0.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameter analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'FG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'FG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '31'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '31'}, {'comment': 'Randomized', 'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Consent withdrawn by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Exclusion criteria finally met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 20 centers in the United States of America. Overall, 214 participants were screened between January 2011 and April 2011. Screen failures were mainly due to exclusion criteria met.', 'preAssignmentDetails': 'Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1 ratio after confirmation of selection criteria. 92 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'BG001', 'title': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.'}, {'id': 'BG002', 'title': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '56.9', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L', 'classes': [{'categories': [{'measurements': [{'value': '3.138', 'spread': '0.469', 'groupId': 'BG000'}, {'value': '3.101', 'spread': '0.402', 'groupId': 'BG001'}, {'value': '3.288', 'spread': '0.564', 'groupId': 'BG002'}, {'value': '3.174', 'spread': '0.484', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-C in mg/dL', 'classes': [{'categories': [{'measurements': [{'value': '121.2', 'spread': '18.1', 'groupId': 'BG000'}, {'value': '119.7', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '126.9', 'spread': '21.8', 'groupId': 'BG002'}, {'value': '122.6', 'spread': '18.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'dispFirstSubmitDate': '2012-12-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2011-02-01', 'dispFirstSubmitQcDate': '2012-12-12', 'resultsFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2011-02-01', 'dispFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-21', 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis', 'timeFrame': 'From Baseline to Week 8 (LOCF)', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward \\[LOCF\\] method.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis', 'timeFrame': 'From baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.'}, {'measure': 'Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis', 'timeFrame': 'From baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.'}, {'measure': 'Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis', 'timeFrame': 'Week 8 (LOCF)'}, {'measure': 'Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis', 'timeFrame': 'From baseline to Week 8 (LOCF)', 'description': 'Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).'}, {'measure': 'Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis', 'timeFrame': 'From Baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.'}, {'measure': 'Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis', 'timeFrame': 'From Baseline to Week 8 (LOCF)', 'description': 'Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['10020603'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '23113833', 'type': 'RESULT', 'citation': 'Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med. 2012 Nov 15;367(20):1891-900. doi: 10.1056/NEJMoa1201832. Epub 2012 Oct 31.'}, {'pmid': '25060413', 'type': 'RESULT', 'citation': 'Gaudet D, Kereiakes DJ, McKenney JM, Roth EM, Hanotin C, Gipe D, Du Y, Ferrand AC, Ginsberg HN, Stein EA. Effect of alirocumab, a monoclonal proprotein convertase subtilisin/kexin 9 antibody, on lipoprotein(a) concentrations (a pooled analysis of 150 mg every two weeks dosing from phase 2 trials). Am J Cardiol. 2014 Sep 1;114(5):711-5. doi: 10.1016/j.amjcard.2014.05.060. Epub 2014 Jun 18.'}, {'pmid': '30183102', 'type': 'DERIVED', 'citation': 'Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.'}, {'pmid': '26872608', 'type': 'DERIVED', 'citation': 'Toth PP, Hamon SC, Jones SR, Martin SS, Joshi PH, Kulkarni KR, Banerjee P, Hanotin C, Roth EM, McKenney JM. Effect of alirocumab on specific lipoprotein non-high-density lipoprotein cholesterol and subfractions as measured by the vertical auto profile method: analysis of 3 randomized trials versus placebo. Lipids Health Dis. 2016 Feb 13;15:28. doi: 10.1186/s12944-016-0197-4.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg.\n\nSecondary Objectives:\n\n* To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.\n* To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg.\n* To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin.\n* To evaluate the development of anti-alirocumab antibodies.\n* To evaluate the pharmacokinetics of alirocumab.', 'detailedDescription': 'The duration of study participation depended on the status of the patient at screening:\n\n* For participants receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening, the study participation was to be approximately 17 weeks including a screening period of 1 week, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.\n* For participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants, the study participation was to be approximately 23 weeks with a screening period of 1 week, a run-in treatment period with atorvastatin 10 mg of 6 weeks, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n\\- Participants receiving a lipid-lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants with primary hypercholesterolemia if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy\n\nOR\n\n\\- Participants with primary hypercholesterolemia treated with stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit.\n\nExclusion criteria:\n\n1. LDL-C \\< 100 mg/dL (\\< 2.59 mmol/L) at Week -1 (V1):\n\n * After the run-in period on atorvastatin 10 mg for participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to the screening period, or drug naive participants.\n\n OR\n * At the first visit for participants who are being treated with atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening visit.\n2. Participants not previously instructed on a cholesterol-lowering diet.\n3. Participants with type 1 diabetes.\n4. Participants with type 2 diabetes treated with insulin.\n5. Participants with type 2 diabetes and with an HbA1c ≥ 8.5% at screening visit (considered poorly controlled).\n6. Laboratory findings measured before randomization:\n\n * Triglycerides (TG) \\> 350 mg/dL (\\> 3.95 mmol/L) at screening visit.\n * Positive serum or urine pregnancy test in females of childbearing potential.\n7. Pregnant or breast-feeding women.\n8. Women of childbearing potential with no effective contraceptive method.\n\nThe above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01288469', 'briefTitle': 'Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose/Dose Regimen, Multicenter Study Evaluating the Efficacy and Safety of SAR236553 When Co-administered With 80 mg of Atorvastatin Over 8 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥2.59 mmol/L) on Atorvastatin 10 mg', 'orgStudyIdInfo': {'id': 'DFI11566'}, 'secondaryIdInfos': [{'id': 'U1111-1117-9994', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Atorvastatin 80 mg', 'description': 'Placebo (for alirocumab) subcutaneous (SC) administration every 2 weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.', 'interventionNames': ['Drug: Placebo (for alirocumab)', 'Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Alirocumab + Atorvastatin 10 mg', 'description': 'Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.', 'interventionNames': ['Drug: Alirocumab', 'Drug: Atorvastatin', 'Drug: Placebo (for atorvastatin)']}, {'type': 'EXPERIMENTAL', 'label': 'Alirocumab + Atorvastatin 80 mg', 'description': 'Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.', 'interventionNames': ['Drug: Alirocumab', 'Drug: Atorvastatin']}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'otherNames': ['SAR236553', 'REGN727'], 'description': 'One subcutaneous (SC) injection in the abdomen only.', 'armGroupLabels': ['Alirocumab + Atorvastatin 10 mg', 'Alirocumab + Atorvastatin 80 mg']}, {'name': 'Placebo (for alirocumab)', 'type': 'DRUG', 'description': 'One SC injection in the abdomen only.', 'armGroupLabels': ['Placebo + Atorvastatin 80 mg']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Over-encapsulated tablet orally once daily in the evening with dinner.', 'armGroupLabels': ['Alirocumab + Atorvastatin 10 mg', 'Alirocumab + Atorvastatin 80 mg', 'Placebo + Atorvastatin 80 mg']}, {'name': 'Placebo (for atorvastatin)', 'type': 'DRUG', 'description': 'One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.', 'armGroupLabels': ['Alirocumab + Atorvastatin 10 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840616', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840601', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840610', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840608', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33166', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840603', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '32223', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840611', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840618', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33138', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840612', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33138', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840614', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33609', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840607', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840605', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840619', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '08817', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 840604', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 840606', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 840615', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 840617', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97404', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number 840602', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '23227', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 840621', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site Number 840609', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '53575', 'city': 'Oregon', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigational Site Number 840613', 'geoPoint': {'lat': 42.92611, 'lon': -89.38456}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}