Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT01652703
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2012-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
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': 'C577155', 'term': 'evolocumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 6, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.', 'otherNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Evolocumab Q2W 70 MG', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.', 'otherNumAtRisk': 49, 'otherNumAffected': 10, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Evolocumab Q2W 140 MG', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 9, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Evolocumab Q4W 280 MG', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.', 'otherNumAtRisk': 51, 'otherNumAffected': 12, 'seriousNumAtRisk': 51, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Evolocumab Q4W 420 MG', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.', 'otherNumAtRisk': 53, 'otherNumAffected': 8, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carcinoid tumour of the caecum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.71', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '-55.56', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '-71.32', 'spread': '2.16', 'groupId': 'OG003'}, {'value': '-58.10', 'spread': '2.33', 'groupId': 'OG004'}, {'value': '-63.89', 'spread': '2.27', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-68.61', 'ciLowerLimit': '-74.51', 'ciUpperLimit': '-62.71', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.99', 'estimateComment': 'Placebo is the reference', 'groupDescription': 'The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.85', 'ciLowerLimit': '-58.84', 'ciUpperLimit': '-46.86', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.03', 'estimateComment': 'Placebo is the reference', 'groupDescription': 'The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-63.94', 'ciLowerLimit': '-70.23', 'ciUpperLimit': '-57.66', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.18', 'estimateComment': 'Placebo is the reference', 'groupDescription': 'The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.16', 'ciLowerLimit': '-64.51', 'ciUpperLimit': '-51.81', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.21', 'estimateComment': 'Placebo is the reference', 'groupDescription': 'The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'LDL-C was measured using ultracentrifugation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-77.2', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '-98.0', 'spread': '3.6', 'groupId': 'OG003'}, {'value': '-79.9', 'spread': '3.4', 'groupId': 'OG004'}, {'value': '-87.4', 'spread': '3.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-96.3', 'ciLowerLimit': '-106.0', 'ciUpperLimit': '-86.5', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-75.5', 'ciLowerLimit': '-85.4', 'ciUpperLimit': '-65.5', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.0', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-88.2', 'ciLowerLimit': '-97.4', 'ciUpperLimit': '-79.0', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.7', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-80.7', 'ciLowerLimit': '-90.0', 'ciUpperLimit': '-71.4', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.7', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'LDL-C was measured using ultracentrifugation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an LDL-C Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '66.0', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '96.0', 'spread': '3.6', 'groupId': 'OG003'}, {'value': '80.4', 'spread': '3.4', 'groupId': 'OG004'}, {'value': '82.4', 'spread': '3.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1945.68', 'ciLowerLimit': '89.64', 'ciUpperLimit': '42232.63', 'pValueComment': 'Testing based on a significance level of 0.05.', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '281.13', 'ciLowerLimit': '14.74', 'ciUpperLimit': '5360.92', 'pValueComment': 'Testing based on a significance level of 0.05.', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '536.45', 'ciLowerLimit': '28.37', 'ciUpperLimit': '10143.40', 'pValueComment': 'Testing based on a significance level of 0.05.', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '595.59', 'ciLowerLimit': '31.11', 'ciUpperLimit': '11402.67', 'pValueComment': 'Testing based on a significance level of 0.05.', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'An LDL-C response was defined as LDL-C \\< 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.20', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '-51.66', 'spread': '2.00', 'groupId': 'OG002'}, {'value': '-64.76', 'spread': '1.94', 'groupId': 'OG003'}, {'value': '-53.00', 'spread': '2.17', 'groupId': 'OG004'}, {'value': '-57.53', 'spread': '2.12', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.56', 'ciLowerLimit': '-67.85', 'ciUpperLimit': '-57.27', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.68', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.46', 'ciLowerLimit': '-54.83', 'ciUpperLimit': '-44.08', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.72', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.08', 'ciLowerLimit': '-63.93', 'ciUpperLimit': '-52.22', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.96', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.54', 'ciLowerLimit': '-59.46', 'ciUpperLimit': '-47.63', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.99', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Apolipoprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.90', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '-47.65', 'spread': '1.88', 'groupId': 'OG002'}, {'value': '-61.59', 'spread': '1.82', 'groupId': 'OG003'}, {'value': '-47.16', 'spread': '2.03', 'groupId': 'OG004'}, {'value': '-53.22', 'spread': '1.98', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-60.69', 'ciLowerLimit': '-65.67', 'ciUpperLimit': '-55.72', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.52', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.75', 'ciLowerLimit': '-51.80', 'ciUpperLimit': '-41.70', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.56', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.44', 'ciLowerLimit': '-58.91', 'ciUpperLimit': '-47.97', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.77', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.37', 'ciLowerLimit': '-52.90', 'ciUpperLimit': '-41.85', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.80', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in VLDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.23', 'spread': '8.55', 'groupId': 'OG000'}, {'value': '7.26', 'spread': '6.87', 'groupId': 'OG001'}, {'value': '-16.02', 'spread': '8.74', 'groupId': 'OG002'}, {'value': '-26.26', 'spread': '8.44', 'groupId': 'OG003'}, {'value': '-13.56', 'spread': '6.80', 'groupId': 'OG004'}, {'value': '-22.56', 'spread': '6.71', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.49', 'ciLowerLimit': '-57.71', 'ciUpperLimit': '-11.26', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.75', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.25', 'ciLowerLimit': '-47.83', 'ciUpperLimit': '-0.68', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.93', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.82', 'ciLowerLimit': '-48.32', 'ciUpperLimit': '-11.32', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.36', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '0.028', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.82', 'ciLowerLimit': '-39.41', 'ciUpperLimit': '-2.22', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.41', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.82', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '-42.04', 'spread': '1.98', 'groupId': 'OG002'}, {'value': '-51.81', 'spread': '1.91', 'groupId': 'OG003'}, {'value': '-44.11', 'spread': '2.10', 'groupId': 'OG004'}, {'value': '-45.47', 'spread': '2.05', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.98', 'ciLowerLimit': '-52.21', 'ciUpperLimit': '-41.76', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.64', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.22', 'ciLowerLimit': '-42.52', 'ciUpperLimit': '-31.91', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.68', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.66', 'ciLowerLimit': '-52.32', 'ciUpperLimit': '-41.00', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.86', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.30', 'ciLowerLimit': '-51.02', 'ciUpperLimit': '-39.58', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.89', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'OG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'OG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.18', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-50.71', 'spread': '2.19', 'groupId': 'OG002'}, {'value': '-64.53', 'spread': '2.12', 'groupId': 'OG003'}, {'value': '-50.79', 'spread': '2.22', 'groupId': 'OG004'}, {'value': '-56.31', 'spread': '2.16', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.35', 'ciLowerLimit': '-67.14', 'ciUpperLimit': '-55.56', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.93', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.53', 'ciLowerLimit': '-53.41', 'ciUpperLimit': '-41.65', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.98', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.75', 'ciLowerLimit': '-63.73', 'ciUpperLimit': '-51.77', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.03', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.22', 'ciLowerLimit': '-58.27', 'ciUpperLimit': '-46.18', 'pValueComment': 'Testing based on a significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.06', 'estimateComment': 'Placebo is the reference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included treatment group and stratification factor of screening LDL-C level.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; missing data were imputed using LOCF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'FG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'FG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'FG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'FG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '53'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Japanese men or women ≥ 20 to ≤ 80 years of age and who were at high risk for cardiovascular events, on a stable dose of an approved statin (with or without ezetimibe) and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 115 mg/dL.\n\nFirst patient enrolled on 10 July 2012; last patient enrolled 19 February 2013.', 'preAssignmentDetails': 'Randomization was stratified by screening LDL-C level (\\< 130 mg/dL \\[3.4 mmol/L\\] vs\n\n≥ 130 mg/dL) and by diagnosis of heterozygous familial hypercholesterolemia (HeFH) (yes vs no).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '307', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.'}, {'id': 'BG002', 'title': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'BG003', 'title': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.'}, {'id': 'BG004', 'title': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'BG005', 'title': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '60.8', 'spread': '9.2', 'groupId': 'BG003'}, {'value': '61.6', 'spread': '9.6', 'groupId': 'BG004'}, {'value': '61.3', 'spread': '9.9', 'groupId': 'BG005'}, {'value': '61.5', 'spread': '9.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '114', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '193', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '307', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor: LDL Level', 'classes': [{'title': '< 130 mg/dL', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '98', 'groupId': 'BG006'}]}]}, {'title': '≥ 130 mg/dL', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '209', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor: Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '287', 'groupId': 'BG006'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'LDL-C Concentration', 'classes': [{'categories': [{'measurements': [{'value': '144.4', 'spread': '18.1', 'groupId': 'BG000'}, {'value': '141.8', 'spread': '23.4', 'groupId': 'BG001'}, {'value': '143.6', 'spread': '20.6', 'groupId': 'BG002'}, {'value': '140.7', 'spread': '23.3', 'groupId': 'BG003'}, {'value': '141.0', 'spread': '21.2', 'groupId': 'BG004'}, {'value': '139.7', 'spread': '18.8', 'groupId': 'BG005'}, {'value': '141.8', 'spread': '20.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'LDL-C was measured using ultracentrifugation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '171.3', 'spread': '23.0', 'groupId': 'BG000'}, {'value': '168.7', 'spread': '26.1', 'groupId': 'BG001'}, {'value': '170.6', 'spread': '27.2', 'groupId': 'BG002'}, {'value': '166.3', 'spread': '26.2', 'groupId': 'BG003'}, {'value': '165.5', 'spread': '24.4', 'groupId': 'BG004'}, {'value': '166.7', 'spread': '23.5', 'groupId': 'BG005'}, {'value': '168.2', 'spread': '25.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B Concentration', 'classes': [{'categories': [{'measurements': [{'value': '114.6', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '112.5', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '113.1', 'spread': '19.2', 'groupId': 'BG002'}, {'value': '109.4', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '109.6', 'spread': '16.9', 'groupId': 'BG004'}, {'value': '109.8', 'spread': '15.9', 'groupId': 'BG005'}, {'value': '111.5', 'spread': '16.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very Low-Density Lipoprotein Cholesterol (VLDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '25.6', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '24.6', 'spread': '10.5', 'groupId': 'BG004'}, {'value': '27.0', 'spread': '12.0', 'groupId': 'BG005'}, {'value': '26.4', 'spread': '11.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol/HDL-C Ratio', 'classes': [{'categories': [{'measurements': [{'value': '4.380', 'spread': '0.949', 'groupId': 'BG000'}, {'value': '4.317', 'spread': '1.075', 'groupId': 'BG001'}, {'value': '4.366', 'spread': '1.177', 'groupId': 'BG002'}, {'value': '4.302', 'spread': '1.039', 'groupId': 'BG003'}, {'value': '4.228', 'spread': '0.993', 'groupId': 'BG004'}, {'value': '4.210', 'spread': '0.955', 'groupId': 'BG005'}, {'value': '4.300', 'spread': '1.026', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B/Apolipoprotein A-1 Ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.750', 'spread': '0.150', 'groupId': 'BG000'}, {'value': '0.741', 'spread': '0.177', 'groupId': 'BG001'}, {'value': '0.743', 'spread': '0.177', 'groupId': 'BG002'}, {'value': '0.722', 'spread': '0.163', 'groupId': 'BG003'}, {'value': '0.725', 'spread': '0.151', 'groupId': 'BG004'}, {'value': '0.714', 'spread': '0.158', 'groupId': 'BG005'}, {'value': '0.732', 'spread': '0.162', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (all randomized participants who received at least 1 dose of investigational product).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2014-05-12', 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2012-07-26', 'dispFirstSubmitQcDate': '2014-05-12', 'resultsFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2012-07-26', 'dispFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-03', 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'LDL-C was measured using ultracentrifugation.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'LDL-C was measured using ultracentrifugation.'}, {'measure': 'Percentage of Participants With an LDL-C Response at Week 12', 'timeFrame': 'Week 12', 'description': 'An LDL-C response was defined as LDL-C \\< 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.'}, {'measure': 'Percent Change From Baseline to Week 12 in Non-HDL-C', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline to Week 12 in Apolipoprotein B', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline to Week 12 in VLDL-C', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio', 'timeFrame': 'Baseline and Week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Japanese, hypercholesterolemia, high risk for cardiovascular events'], 'conditions': ['Hypercholesterolemia and High Risk for Cardiovascular Events']}, 'referencesModule': {'references': [{'pmid': '28367845', 'type': 'BACKGROUND', 'citation': 'Hirayama A, Yamashita S, Inomata H, Kassahun H, Cyrille M, Ruzza A, Yoshida M, Kiyosue A, Ma Y, Teramoto T. One-Year Efficacy and Safety of Evolocumab in Japanese Patients - A Pooled Analysis From the Open-Label Extension OSLER Studies. Circ J. 2017 Jun 23;81(7):1029-1035. doi: 10.1253/circj.CJ-16-1016. Epub 2017 Mar 29.'}, {'pmid': '28249876', 'type': 'BACKGROUND', 'citation': 'Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.'}, {'pmid': '29353350', 'type': 'BACKGROUND', 'citation': 'Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0 mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction \\< 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.'}, 'identificationModule': {'nctId': 'NCT01652703', 'acronym': 'AMG145', 'briefTitle': 'A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia and High Cardiovascular Risk', 'orgStudyIdInfo': {'id': '20110231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Q4W', 'description': 'Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab 70 mg Q2W', 'description': 'Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.', 'interventionNames': ['Biological: Evolocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab 140 mg Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.', 'interventionNames': ['Biological: Evolocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab 280 mg Q4W', 'description': 'Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.', 'interventionNames': ['Biological: Evolocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab 420 mg Q4W', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.', 'interventionNames': ['Biological: Evolocumab']}], 'interventions': [{'name': 'Evolocumab', 'type': 'BIOLOGICAL', 'otherNames': ['AMG 145', 'Repatha'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Evolocumab 140 mg Q2W', 'Evolocumab 280 mg Q4W', 'Evolocumab 420 mg Q4W', 'Evolocumab 70 mg Q2W']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Placebo Q2W', 'Placebo Q4W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '454-0933', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '455-8530', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '462-0825', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '910-0067', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '910-0803', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '910-0837', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '816-0864', 'city': 'Kasuga-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '500-8384', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '375-0015', 'city': 'Fujioka-shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '371-0022', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '371-0046', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '370-0829', 'city': 'Takasaki-shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '666-0125', 'city': 'Kawanishi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81667, 'lon': 135.41667}}, {'zip': '657-0068', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '317-0077', 'city': 'Hitachi-shi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '306-0041', 'city': 'Koga-shi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '311-4198', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '923-8560', 'city': 'Komatsu-shi', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '760-8557', 'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '781-8555', 'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '613-0911', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '615-8125', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '396-8555', 'city': 'Ina-shi', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '390-0848', 'city': 'Matsumoto-shi', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '392-8510', 'city': 'Suwa-shi', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '567-0876', 'city': 'Ibaraki-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '565-0871', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '560-0082', 'city': 'Toyonaka-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '348-8505', 'city': 'Hanyu-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '350-1305', 'city': 'Sayama-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '335-0023', 'city': 'Toda-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '520-0113', 'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'zip': '113-8421', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '113-8519', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '101-0041', 'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '103-0027', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '192-0918', 'city': 'Hachioji-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '173-8610', 'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '141-0001', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '111-0052', 'city': 'Taito-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '171-0021', 'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}