Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-02 @ 8:17 AM
Study NCT ID:
NCT01709500
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2012-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'C571059', 'term': 'alirocumab'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': '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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'title': 'Clinical Trial Management', 'organization': 'Regeneron Pharmaceuticals, Inc'}, 'certainAgreement': {'otherDetails': "Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline up to Week 78', 'description': 'Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.', 'otherNumAtRisk': 167, 'otherNumAffected': 65, 'seriousNumAtRisk': 167, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.', 'otherNumAtRisk': 81, 'otherNumAffected': 35, 'seriousNumAtRisk': 81, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Non-Cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Hepatitis a', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.4', 'ciLowerLimit': '-58.1', 'ciUpperLimit': '-44.8', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Alirocumab group was compared to the placebo group using an appropriate contrast statement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least- squares (LS) means and standard errors at Week 24 were obtained from a mixed -effect model with repeated measures (MMRM) to account for missing data. All available post -baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.2', 'ciLowerLimit': '-58.7', 'ciUpperLimit': '-45.6', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT (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': 'Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.4', 'ciLowerLimit': '-54.7', 'ciUpperLimit': '-42.2', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.8', 'ciLowerLimit': '-55', 'ciUpperLimit': '-42.5', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.3', 'ciLowerLimit': '-44.1', 'ciUpperLimit': '-34.5', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.8', 'ciLowerLimit': '-44.5', 'ciUpperLimit': '-35.1', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High -Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.7', 'ciLowerLimit': '-51.8', 'ciUpperLimit': '-39.7', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.4', 'ciLowerLimit': '-52.3', 'ciUpperLimit': '-40.4', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.8', 'ciLowerLimit': '-37.4', 'ciUpperLimit': '-28.1', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.5', 'ciLowerLimit': '-39.2', 'ciUpperLimit': '-29.8', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Apo B ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42', 'ciLowerLimit': '-47.8', 'ciUpperLimit': '-36.2', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-HDL-C ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total-C at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.9', 'ciLowerLimit': '-34.5', 'ciUpperLimit': '-25.4', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Threshold for significance ≤ 0.05.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Total--C ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.8', 'ciLowerLimit': '-66.8', 'ciUpperLimit': '-50.8', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off treatment (ITT analysis).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.2', 'ciLowerLimit': '20.9', 'ciUpperLimit': '130', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Very High CV Risk Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL--C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.3', 'ciLowerLimit': '21.4', 'ciUpperLimit': '132.6', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 52', 'description': 'Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '239.7', 'ciLowerLimit': '31.6', 'ciUpperLimit': '1820.3', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '240.6', 'ciLowerLimit': '31.4', 'ciUpperLimit': '1841.7', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-10', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.3', 'ciLowerLimit': '-26.4', 'ciUpperLimit': '-14.2', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '2.8', 'ciUpperLimit': '10.7', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.4', 'spread': '2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '-4.3', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '1.3', 'ciUpperLimit': '7.5', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.1', 'ciLowerLimit': '-25', 'ciUpperLimit': '-13.1', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Lipoprotein (a) ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0147', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '0.9', 'ciUpperLimit': '7.8', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'HDL-C ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-16.1', 'ciUpperLimit': '-1.1', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Fasting triglycerides ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.1475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '5.5', 'pValueComment': 'Threshold for significance ≤ 0.05.', 'groupDescription': 'Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Apo A-1 ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Related to IMP administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Treatment ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '78'}]}]}], 'recruitmentDetails': 'The study was conducted at 26 sites in 4 countries. Overall, 322 participants were screened between 28 Nov 2012 and 26 Apr 2013, 73 of whom were screen failures.', 'preAssignmentDetails': 'Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 (alirocumab: placebo) ratio after confirmation of selection criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78--week treatment duration.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '12.93', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '12.55', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Calculated LDL-C in mmol/L', 'classes': [{'categories': [{'measurements': [{'value': '3.485', 'spread': '1.065', 'groupId': 'BG000'}, {'value': '3.471', 'spread': '1.071', 'groupId': 'BG001'}, {'value': '3.480', 'spread': '1.065', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated LDL-C values were obtained using Friedewald formula.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calculated LDL-C in mg/dL', 'classes': [{'categories': [{'measurements': [{'value': '134.6', 'spread': '41.1', 'groupId': 'BG000'}, {'value': '134.0', 'spread': '41.4', 'groupId': 'BG001'}, {'value': '134.4', 'spread': '41.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated LDL-C values were obtained using Friedewald formula.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-01-24', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2012-10-08', 'dispFirstSubmitQcDate': '2015-01-24', 'resultsFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2012-10-16', 'dispFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-29', 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least- squares (LS) means and standard errors at Week 24 were obtained from a mixed -effect model with repeated measures (MMRM) to account for missing data. All available post -baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).'}, {'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).'}, {'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).'}, {'measure': 'Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).'}, {'measure': 'Percent Change From Baseline in Non-High -Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Apo B at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Total-C at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.'}, {'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off treatment (ITT analysis).'}, {'measure': 'Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis', 'timeFrame': 'Up to Week 52', 'description': 'Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).'}, {'measure': 'Percentage of Very High CV Risk Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL--C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis', 'timeFrame': 'Up to week 52', 'description': 'Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).'}, {'measure': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis', 'timeFrame': 'Up to Week 52', 'description': 'Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).'}, {'measure': 'Percentage of Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis', 'timeFrame': 'Up to Week 52', 'description': 'Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).'}, {'measure': 'Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}, {'measure': 'Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis', 'timeFrame': 'From Baseline to Week 52', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heterozygous Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '34298554', 'type': 'DERIVED', 'citation': 'Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.'}, {'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': '28964736', 'type': 'DERIVED', 'citation': 'Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4.'}, {'pmid': '28391886', 'type': 'DERIVED', 'citation': 'Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.'}, {'pmid': '27777279', 'type': 'DERIVED', 'citation': 'Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.'}, {'pmid': '26330422', 'type': 'DERIVED', 'citation': 'Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.'}, {'pmid': '24842558', 'type': 'DERIVED', 'citation': 'Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with heFH\\* who are not adequately controlled\\*\\* with a maximally-tolerated daily dose\\*\\*\\* of statin with or without other LMT, at a stable dose prior to the screening visit (week -2).\n\n \\*Diagnosis of heFH must be made either by genotyping or by clinical criteria. For those patients not genotyped, the clinical diagnosis may be based on either the Simon Broome criteria for definite FH (Appendix 1) or the WHO/Dutch Lipid Network criteria with a score of \\>8 points (Appendix 2).\n\n \\*\\* "Not adequately controlled" is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) at the screening visit (week -2) in patients with a history of documented CVD (Appendix 3), or LDL-C ≥100 mg/dL (2.59 mmol/L) at the screening visit (week -2) in patients without a history of documented CVD.\n\n \\*\\*\\* "Maximally-tolerated dose" is defined as (any of the following are acceptable):\n * Rosuvastatin 20 mg or 40 mg daily\n * Atorvastatin 40 mg or 80 mg daily\n * Simvastatin 80 mg daily (if already on this dose for \\>1 year - see exclusion criterion #7)\n\n Note: Patients who are not able to be on any of the above statin doses should be treated with the dose of daily atorvastatin, rosuvastatin, or simvastatin which is considered appropriate for the patient, according to the investigator\'s judgment. Some examples of acceptable reasons for a patient taking a lower statin dose include, but are not limited to: adverse effects on higher doses, advanced age, low body mass index, regional practices, local prescribing information, concomitant medications, co-morbid conditions such as impaired glucose tolerance/impaired fasting glucose. The reason(s) will be documented in the case report form (CRF).\n2. Provide signed informed consent\n\nExclusion Criteria:\n\n1. Patient without diagnosis of heFH made either by genotyping or by clinical criteria\n2. LDL-C \\<70 mg/dL (\\<1.81 mmol/L) at the screening visit (week-2) in patients with history of documented cardiovascular disease\n3. LDL-C \\<100 mg/dL (\\<2.59 mmol/L) at the screening visit (week -2) in patients without history of documented cardiovascular disease\n4. Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (week -2) and from screening to randomization\n5. Currently taking another statin than simvastatin, atorvastatin, or rosuvastatin\n6. Simvastatin, atorvastatin, or rosuvastatin is not taken daily or not taken at a registered dose\n7. Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than 1 year, who are eligible)\n8. Use of fibrates, other than fenofibrate within 6 weeks of the screening visit (week-2) or between screening and randomization visits\n9. Use of nutraceutical products or over-the-counter therapies that may affect lipids which have not been at a stable dose/amount for at least 4 weeks prior to the screening visit (week -2) or between screening and randomization visits\n10. Use of red yeast rice products within 4 weeks of the screening visit (week-2), or between screening and randomization visits\n11. Patient who has received plasmapheresis treatment within 2 months prior to the screening visit (week -2), or has plans to receive it during the study\n12. Recent (within 3 months prior to the screening visit \\[week -2\\] or between screening and randomization visits) MI, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack (TIA), carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease\n\n(The inclusion/exclusion criteria provided above is not intended to contain all considerations relevant to a participant\'s potential participation in this clinical trial).'}, 'identificationModule': {'nctId': 'NCT01709500', 'acronym': 'ODYSSEY FH II', 'briefTitle': 'Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy', 'orgStudyIdInfo': {'id': 'R727-CL-1112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alirocumab 75 mg/up to 150 mg', 'description': 'Alirocumab 75 mg every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.', 'interventionNames': ['Drug: LMT (atorvastatin, simvastatin, or rosuvastatin)', 'Drug: alirocumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to alirocumab SC injection for 78-week treatment duration.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LMT (atorvastatin, simvastatin, or rosuvastatin)', 'type': 'DRUG', 'armGroupLabels': ['Alirocumab 75 mg/up to 150 mg']}, {'name': 'alirocumab', 'type': 'DRUG', 'otherNames': ['REGN727', 'SAR236553'], 'description': 'Alirocumab administered as a subcutaneous (SC) injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.', 'armGroupLabels': ['Alirocumab 75 mg/up to 150 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Trutnov', 'country': 'Czechia', 'geoPoint': {'lat': 50.56101, 'lon': 15.9127}}, {'city': 'Vyškov', 'country': 'Czechia', 'geoPoint': {'lat': 49.27747, 'lon': 16.99897}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Enschede', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Goes', 'country': 'Netherlands', 'geoPoint': {'lat': 51.50417, 'lon': 3.88889}}, {'city': 'Groningen', 'country': 'Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Hoogeveen', 'country': 'Netherlands', 'geoPoint': {'lat': 52.7225, 'lon': 6.47639}}, {'city': 'Hoorn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Sittard- Geleen', 'country': 'Netherlands'}, {'city': 'Utrecht (2 Locations)', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Venlo', 'country': 'Netherlands', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'city': 'Waalwijk', 'country': 'Netherlands', 'geoPoint': {'lat': 51.6825, 'lon': 5.07083}}, {'city': 'Oslo', 'country': 'Norway', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Middlesex', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'West Bromwich', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.51868, 'lon': -1.9945}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}