Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-02 @ 10:13 PM
Study NCT ID:
NCT00540293
Status:
COMPLETED
Last Update Posted:
2021-03-12
First Post:
2007-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Total Treatment Group (All Subjects Who Received Atorvastatin)', 'description': 'this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors', 'otherNumAffected': 14, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 425, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 425, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerabral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 425, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '77.9', 'upperLimit': '85.5'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '67.3', 'upperLimit': '96.0'}, {'value': '95.5', 'groupId': 'OG002', 'lowerLimit': '84.5', 'upperLimit': '99.4'}, {'value': '79.9', 'groupId': 'OG003', 'lowerLimit': '75.2', 'upperLimit': '84.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'LDL-C Responders by visit and by risk group - FAS', 'unitOfMeasure': 'Percent subjects achieved LDL-C target', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'LDL-C baseline', 'categories': [{'measurements': [{'value': '151.7', 'groupId': 'OG000', 'lowerLimit': '149.1', 'upperLimit': '154.4'}, {'value': '187.0', 'groupId': 'OG001', 'lowerLimit': '179.8', 'upperLimit': '194.1'}, {'value': '160.6', 'groupId': 'OG002', 'lowerLimit': '154.3', 'upperLimit': '167.0'}, {'value': '147.7', 'groupId': 'OG003', 'lowerLimit': '144.9', 'upperLimit': '150.5'}]}]}, {'title': 'LDL-C (week 4)', 'categories': [{'measurements': [{'value': '-63.5', 'groupId': 'OG000', 'lowerLimit': '-66.2', 'upperLimit': '-60.8'}, {'value': '-73.8', 'groupId': 'OG001', 'lowerLimit': '-82.7', 'upperLimit': '-64.8'}, {'value': '-65.1', 'groupId': 'OG002', 'lowerLimit': '-73.5', 'upperLimit': '-56.7'}, {'value': '-62.4', 'groupId': 'OG003', 'lowerLimit': '-65.4', 'upperLimit': '-59.4'}]}]}, {'title': 'LDL-C (week 8)', 'categories': [{'measurements': [{'value': '-65.3', 'groupId': 'OG000', 'lowerLimit': '-68.0', 'upperLimit': '-62.5'}, {'value': '-77.6', 'groupId': 'OG001', 'lowerLimit': '-88.3', 'upperLimit': '-66.9'}, {'value': '-64.2', 'groupId': 'OG002', 'lowerLimit': '-72.4', 'upperLimit': '-56.0'}, {'value': '-64.4', 'groupId': 'OG003', 'lowerLimit': '-67.4', 'upperLimit': '-61.4'}]}]}, {'title': 'HDL-C baseline', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '49.3'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '47.4', 'upperLimit': '53.7'}, {'value': '48.0', 'groupId': 'OG002', 'lowerLimit': '45.5', 'upperLimit': '50.5'}, {'value': '48.2', 'groupId': 'OG003', 'lowerLimit': '47.0', 'upperLimit': '49.3'}]}]}, {'title': 'HDL-C (week 4)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '0.9'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '2.0'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '5.7'}, {'value': '-0.2', 'groupId': 'OG003', 'lowerLimit': '-1.1', 'upperLimit': '0.7'}]}]}, {'title': 'HDL-C (week 8)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '1.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '5.9'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '5.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-1.0', 'upperLimit': '1.0'}]}]}, {'title': 'Non-HDL-C baseline', 'categories': [{'measurements': [{'value': '175.5', 'groupId': 'OG000', 'lowerLimit': '172.5', 'upperLimit': '178.5'}, {'value': '209.9', 'groupId': 'OG001', 'lowerLimit': '201.0', 'upperLimit': '218.8'}, {'value': '187.1', 'groupId': 'OG002', 'lowerLimit': '179.9', 'upperLimit': '194.4'}, {'value': '171.1', 'groupId': 'OG003', 'lowerLimit': '167.9', 'upperLimit': '174.4'}]}]}, {'title': 'Non-HDL-C (week 4)', 'categories': [{'measurements': [{'value': '-69.4', 'groupId': 'OG000', 'lowerLimit': '-72.3', 'upperLimit': '-66.5'}, {'value': '-75.4', 'groupId': 'OG001', 'lowerLimit': '-87.8', 'upperLimit': '-63.1'}, {'value': '-71.3', 'groupId': 'OG002', 'lowerLimit': '-80.2', 'upperLimit': '-62.5'}, {'value': '-68.6', 'groupId': 'OG003', 'lowerLimit': '-71.8', 'upperLimit': '-65.4'}]}]}, {'title': 'Non-HDL-C (week 8)', 'categories': [{'measurements': [{'value': '-70.7', 'groupId': 'OG000', 'lowerLimit': '-73.7', 'upperLimit': '-67.7'}, {'value': '-80.9', 'groupId': 'OG001', 'lowerLimit': '-93.9', 'upperLimit': '-67.8'}, {'value': '-72.1', 'groupId': 'OG002', 'lowerLimit': '-80.3', 'upperLimit': '-64.0'}, {'value': '-69.7', 'groupId': 'OG003', 'lowerLimit': '-73.0', 'upperLimit': '-66.4'}]}]}, {'title': 'LDL-C/HDL-C ratio baseline', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.3'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '4.0'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '3.6'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '3.3'}]}]}, {'title': 'LDL-C/HDL-C Ratio (Scalar) week 4', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-1.3'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '-1.1'}, {'value': '-1.5', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-1.3'}, {'value': '-1.3', 'groupId': 'OG003', 'lowerLimit': '-1.4', 'upperLimit': '-1.3'}]}]}, {'title': 'LDL-C/HDL-C Ratio (Scalar) week 8', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-1.3'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-1.2'}, {'value': '-1.5', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-1.3'}, {'value': '-1.4', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '-1.3'}]}]}, {'title': 'TC baseline', 'categories': [{'measurements': [{'value': '223.9', 'groupId': 'OG000', 'lowerLimit': '220.8', 'upperLimit': '227.0'}, {'value': '262.3', 'groupId': 'OG001', 'lowerLimit': '253.9', 'upperLimit': '270.8'}, {'value': '235.1', 'groupId': 'OG002', 'lowerLimit': '228.0', 'upperLimit': '242.3'}, {'value': '219.3', 'groupId': 'OG003', 'lowerLimit': '216.0', 'upperLimit': '222.6'}]}]}, {'title': 'TC (week 4)', 'categories': [{'measurements': [{'value': '-69.4', 'groupId': 'OG000', 'lowerLimit': '-72.4', 'upperLimit': '-66.4'}, {'value': '-78.2', 'groupId': 'OG001', 'lowerLimit': '-89.3', 'upperLimit': '-67.1'}, {'value': '-68.0', 'groupId': 'OG002', 'lowerLimit': '-77.2', 'upperLimit': '-58.8'}, {'value': '-68.8', 'groupId': 'OG003', 'lowerLimit': '-72.2', 'upperLimit': '-65.5'}]}]}, {'title': 'TC (week 8)', 'categories': [{'measurements': [{'value': '-70.4', 'groupId': 'OG000', 'lowerLimit': '-73.4', 'upperLimit': '-67.3'}, {'value': '-80.7', 'groupId': 'OG001', 'lowerLimit': '-94.2', 'upperLimit': '-67.3'}, {'value': '-69.1', 'groupId': 'OG002', 'lowerLimit': '-77.2', 'upperLimit': '-61.1'}, {'value': '-69.7', 'groupId': 'OG003', 'lowerLimit': '-73.1', 'upperLimit': '-66.2'}]}]}, {'title': 'TG baseline', 'categories': [{'measurements': [{'value': '154.1', 'groupId': 'OG000', 'lowerLimit': '146.2', 'upperLimit': '162.1'}, {'value': '150.7', 'groupId': 'OG001', 'lowerLimit': '128.6', 'upperLimit': '172.8'}, {'value': '152.3', 'groupId': 'OG002', 'lowerLimit': '130.3', 'upperLimit': '174.2'}, {'value': '154.7', 'groupId': 'OG003', 'lowerLimit': '145.6', 'upperLimit': '163.7'}]}]}, {'title': 'TG (week 4)', 'categories': [{'measurements': [{'value': '-29.1', 'groupId': 'OG000', 'lowerLimit': '-35.5', 'upperLimit': '-22.7'}, {'value': '-11.5', 'groupId': 'OG001', 'lowerLimit': '-43.0', 'upperLimit': '20.0'}, {'value': '-16.6', 'groupId': 'OG002', 'lowerLimit': '-31.4', 'upperLimit': '-1.8'}, {'value': '-32.1', 'groupId': 'OG003', 'lowerLimit': '-39.2', 'upperLimit': '-25.1'}]}]}, {'title': 'TG (week 8)', 'categories': [{'measurements': [{'value': '-29.3', 'groupId': 'OG000', 'lowerLimit': '-37.9', 'upperLimit': '-20.7'}, {'value': '-20.9', 'groupId': 'OG001', 'lowerLimit': '-51.3', 'upperLimit': '9.5'}, {'value': '-18.5', 'groupId': 'OG002', 'lowerLimit': '-36.3', 'upperLimit': '-0.7'}, {'value': '-31.4', 'groupId': 'OG003', 'lowerLimit': '-41.3', 'upperLimit': '-21.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4 and 8', 'description': 'Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride', 'unitOfMeasure': 'mg/dL (ratio for Scalar)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'LDL-C % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-40.9', 'groupId': 'OG000', 'lowerLimit': '-42.3', 'upperLimit': '-39.5'}, {'value': '-39.5', 'groupId': 'OG001', 'lowerLimit': '-44.1', 'upperLimit': '-35.0'}, {'value': '-39.6', 'groupId': 'OG002', 'lowerLimit': '-43.8', 'upperLimit': '-35.5'}, {'value': '-41.2', 'groupId': 'OG003', 'lowerLimit': '-42.8', 'upperLimit': '-39.6'}]}]}, {'title': 'LDL-C % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-42.0', 'groupId': 'OG000', 'lowerLimit': '-43.4', 'upperLimit': '-40.7'}, {'value': '-41.2', 'groupId': 'OG001', 'lowerLimit': '-46.6', 'upperLimit': '-35.8'}, {'value': '-39.3', 'groupId': 'OG002', 'lowerLimit': '-43.5', 'upperLimit': '-35.1'}, {'value': '-42.5', 'groupId': 'OG003', 'lowerLimit': '-44.0', 'upperLimit': '-41.0'}]}]}, {'title': 'HDL-C % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '5.6'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '13.1'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '-0.8', 'upperLimit': '2.9'}]}]}, {'title': 'HDL-C % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.4'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '13.2'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '11.1'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '-0.2', 'upperLimit': '3.9'}]}]}, {'title': 'Non-HDL-C % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-38.7', 'groupId': 'OG000', 'lowerLimit': '-40.1', 'upperLimit': '-37.4'}, {'value': '-35.5', 'groupId': 'OG001', 'lowerLimit': '-40.9', 'upperLimit': '-30.1'}, {'value': '-37.7', 'groupId': 'OG002', 'lowerLimit': '-41.5', 'upperLimit': '-33.8'}, {'value': '-39.1', 'groupId': 'OG003', 'lowerLimit': '-40.6', 'upperLimit': '-37.7'}]}]}, {'title': 'Non-HDL-C % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-39.4', 'groupId': 'OG000', 'lowerLimit': '-40.7', 'upperLimit': '-38.1'}, {'value': '-38.2', 'groupId': 'OG001', 'lowerLimit': '-44.1', 'upperLimit': '-32.2'}, {'value': '-38.3', 'groupId': 'OG002', 'lowerLimit': '-42.1', 'upperLimit': '-34.5'}, {'value': '-39.7', 'groupId': 'OG003', 'lowerLimit': '-41.1', 'upperLimit': '-38.2'}]}]}, {'title': 'LDL-C/HDL-C ratio % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-41.3', 'groupId': 'OG000', 'lowerLimit': '-43.0', 'upperLimit': '-39.7'}, {'value': '-36.7', 'groupId': 'OG001', 'lowerLimit': '-44.3', 'upperLimit': '-29.0'}, {'value': '-44.1', 'groupId': 'OG002', 'lowerLimit': '-48.9', 'upperLimit': '-39.3'}, {'value': '-41.4', 'groupId': 'OG003', 'lowerLimit': '-43.2', 'upperLimit': '-39.6'}]}]}, {'title': 'LDL-C/HDL-C ratio % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-42.6', 'groupId': 'OG000', 'lowerLimit': '-44.3', 'upperLimit': '-40.9'}, {'value': '-41.6', 'groupId': 'OG001', 'lowerLimit': '-49.5', 'upperLimit': '-33.7'}, {'value': '-42.9', 'groupId': 'OG002', 'lowerLimit': '-48.0', 'upperLimit': '-37.7'}, {'value': '-42.6', 'groupId': 'OG003', 'lowerLimit': '-44.5', 'upperLimit': '-40.8'}]}]}, {'title': 'TC % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-30.3', 'groupId': 'OG000', 'lowerLimit': '-31.4', 'upperLimit': '-29.2'}, {'value': '-29.7', 'groupId': 'OG001', 'lowerLimit': '-33.6', 'upperLimit': '-25.7'}, {'value': '-28.5', 'groupId': 'OG002', 'lowerLimit': '-31.9', 'upperLimit': '-25.2'}, {'value': '-30.6', 'groupId': 'OG003', 'lowerLimit': '-31.9', 'upperLimit': '-29.3'}]}]}, {'title': 'TC % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-30.7', 'groupId': 'OG000', 'lowerLimit': '-31.9', 'upperLimit': '-29.6'}, {'value': '-30.4', 'groupId': 'OG001', 'lowerLimit': '-35.2', 'upperLimit': '-25.5'}, {'value': '-29.2', 'groupId': 'OG002', 'lowerLimit': '-32.3', 'upperLimit': '-26.2'}, {'value': '-31.0', 'groupId': 'OG003', 'lowerLimit': '-32.2', 'upperLimit': '-29.7'}]}]}, {'title': 'TG % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-8.2', 'groupId': 'OG000', 'lowerLimit': '-12.9', 'upperLimit': '-3.6'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '-18.5', 'upperLimit': '27.3'}, {'value': '-8.3', 'groupId': 'OG002', 'lowerLimit': '-17.7', 'upperLimit': '1.2'}, {'value': '-9.3', 'groupId': 'OG003', 'lowerLimit': '-14.4', 'upperLimit': '-4.1'}]}]}, {'title': 'TG % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-9.8', 'groupId': 'OG000', 'lowerLimit': '-14.9', 'upperLimit': '-4.8'}, {'value': '-6.3', 'groupId': 'OG001', 'lowerLimit': '-27.0', 'upperLimit': '14.5'}, {'value': '-7.0', 'groupId': 'OG002', 'lowerLimit': '-20.4', 'upperLimit': '6.4'}, {'value': '-10.5', 'groupId': 'OG003', 'lowerLimit': '-16.2', 'upperLimit': '-4.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 4 and 8', 'description': 'Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).'}, {'type': 'SECONDARY', 'title': 'Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'FAS population responders no titration', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '274', 'groupId': 'OG003'}]}]}, {'title': 'FAS population responders 1-step titration', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'EVAL population responders no titration', 'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}]}]}, {'title': 'EVAL population responders 1-step titration', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'FAS population (no LOCF) no titration', 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}]}, {'title': 'FAS population (no LOCF) 1-step titration', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'LDL-C responders at week 8 by titration status and risk groups - 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FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.108', 'groupId': 'OG000', 'lowerLimit': '0.094', 'upperLimit': '0.126'}, {'value': '0.082', 'groupId': 'OG001', 'lowerLimit': '0.060', 'upperLimit': '0.112'}, {'value': '0.075', 'groupId': 'OG002', 'lowerLimit': '0.059', 'upperLimit': '0.126'}, {'value': '0.122', 'groupId': 'OG003', 'lowerLimit': '0.102', 'upperLimit': '0.137'}]}]}, {'title': 'Median change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-0.008', 'groupId': 'OG000', 'lowerLimit': '-0.014', 'upperLimit': '-0.005'}, {'value': '-0.008', 'groupId': 'OG001', 'lowerLimit': '-0.028', 'upperLimit': '-0.001'}, {'value': '-0.002', 'groupId': 'OG002', 'lowerLimit': '-0.014', 'upperLimit': '0.023'}, {'value': '-0.010', 'groupId': 'OG003', 'lowerLimit': '-0.018', 'upperLimit': '-0.005'}]}]}, {'title': 'Median change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-0.015', 'groupId': 'OG000', 'lowerLimit': '-0.021', 'upperLimit': '-0.009'}, {'value': '-0.011', 'groupId': 'OG001', 'lowerLimit': '-0.034', 'upperLimit': '0.018'}, {'value': '-0.001', 'groupId': 'OG002', 'lowerLimit': '-0.021', 'upperLimit': '0.010'}, {'value': '-0.018', 'groupId': 'OG003', 'lowerLimit': '-0.027', 'upperLimit': '-0.010'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 and 8 weeks', 'description': 'Median baseline, and change from baseline in hs-CRP by risk group - FAS', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).'}, {'type': 'PRIMARY', 'title': 'Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total: sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '82.3', 'upperLimit': '89.2'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '76.5', 'upperLimit': '99.1'}, {'value': '95.5', 'groupId': 'OG002', 'lowerLimit': '84.5', 'upperLimit': '99.4'}, {'value': '84.3', 'groupId': 'OG003', 'lowerLimit': '80.0', 'upperLimit': '87.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'LDL-C Responders by visit and by risk group - full analysis set (FAS)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '343', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'Median % change from baseline (week 4)', 'categories': [{'measurements': [{'value': '-12.346', 'groupId': 'OG000', 'lowerLimit': '-21.429', 'upperLimit': '-4.651'}, {'value': '-13.941', 'groupId': 'OG001', 'lowerLimit': '-35.055', 'upperLimit': '-1.923'}, {'value': '-2.553', 'groupId': 'OG002', 'lowerLimit': '-22.951', 'upperLimit': '25.926'}, {'value': '-16.197', 'groupId': 'OG003', 'lowerLimit': '-24.182', 'upperLimit': '-4.523'}]}]}, {'title': 'Median % change from baseline (week 8)', 'categories': [{'measurements': [{'value': '-18.605', 'groupId': 'OG000', 'lowerLimit': '-24.138', 'upperLimit': '-11.111'}, {'value': '-18.621', 'groupId': 'OG001', 'lowerLimit': '-37.363', 'upperLimit': '20.690'}, {'value': '-1.472', 'groupId': 'OG002', 'lowerLimit': '-26.364', 'upperLimit': '14.925'}, {'value': '-20.561', 'groupId': 'OG003', 'lowerLimit': '-25.333', 'upperLimit': '-12.346'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 and 8 weeks', 'description': 'Percent change from baseline in hs-CRP by risk group - FAS', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'MCP-1 baseline', 'categories': [{'measurements': [{'value': '302.7', 'groupId': 'OG000', 'lowerLimit': '295.0', 'upperLimit': '311.7'}, {'value': '305.2', 'groupId': 'OG001', 'lowerLimit': '267.9', 'upperLimit': '340.6'}, {'value': '317.7', 'groupId': 'OG002', 'lowerLimit': '294.2', 'upperLimit': '386.4'}, {'value': '301.6', 'groupId': 'OG003', 'lowerLimit': '291.7', 'upperLimit': '310.0'}]}]}, {'title': 'MCP-1 change from baseline (week 8)', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '66.7'}, {'value': '-15.0', 'groupId': 'OG001', 'lowerLimit': '-61.4', 'upperLimit': '45.9'}, {'value': '-22.4', 'groupId': 'OG002', 'lowerLimit': '-102.9', 'upperLimit': '42.6'}, {'value': '59.4', 'groupId': 'OG003', 'lowerLimit': '33.6', 'upperLimit': '74.9'}]}]}, {'title': 'IL-6 baseline', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '0.50'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.60'}, {'value': '0.40', 'groupId': 'OG002', 'lowerLimit': '0.30', 'upperLimit': '0.80'}, {'value': '0.50', 'groupId': 'OG003', 'lowerLimit': '0.40', 'upperLimit': '0.60'}]}]}, {'title': 'IL-6 change from baseline (week 8)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '0.00'}, {'value': '-0.10', 'groupId': 'OG002', 'lowerLimit': '-0.30', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'TNF-alpha baseline', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.10'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.30'}, {'value': '0.20', 'groupId': 'OG002', 'lowerLimit': '0.10', 'upperLimit': '0.30'}, {'value': '0.10', 'groupId': 'OG003', 'lowerLimit': '0.10', 'upperLimit': '0.10'}]}]}, {'title': 'TNF-alpha change from baseline (week 8)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-0.10', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, and 8 weeks', 'description': 'Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS', 'unitOfMeasure': 'pg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'N=425 (Total=sum of all risk groups)'}, {'id': 'OG001', 'title': 'Low Risk', 'description': 'N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD \\< 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD \\< 10 %, e.g., subjects in Category 1 or 2.)'}, {'id': 'OG002', 'title': 'Medium Risk', 'description': 'N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)'}, {'id': 'OG003', 'title': 'High Risk', 'description': 'N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk \\> 20 %, e.g., subjects in Category 4.)'}], 'classes': [{'title': 'MCP-1 % change (week 8)', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '22.3'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-18.6', 'upperLimit': '18.7'}, {'value': '-8.0', 'groupId': 'OG002', 'lowerLimit': '-34.2', 'upperLimit': '21.4'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '11.1', 'upperLimit': '24.7'}]}]}, {'title': 'IL-6 % change (week 8)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-50.00', 'upperLimit': '0.00'}, {'value': '-12.50', 'groupId': 'OG002', 'lowerLimit': '-45.45', 'upperLimit': '25.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'TNF-alpha % change (week 8)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-50.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-42.86', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Treatment Group (All Subjects Who Received Atorvastatin)', 'description': 'this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '425'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse event related to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Adverse event not related to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Protocol violation, & subject schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Study was conducted at 20 centers in Korea', 'preAssignmentDetails': 'Participants who were on antilipidemic medications at the time of screening required a 6-week washout period prior to study treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Treatment Group (All Subjects Who Received Atorvastatin)', 'description': 'this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Females between 18 and 80 years', 'categories': [{'measurements': [{'value': '62.9', 'spread': '8.6', 'groupId': 'BG000'}]}]}, {'title': 'Males between 18 and 80 years', 'categories': [{'measurements': [{'value': '58.6', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '195', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '230', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2007-10-04', 'resultsFirstSubmitDate': '2009-05-08', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-05-08', 'studyFirstPostDateStruct': {'date': '2007-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.', 'timeFrame': 'Week 8', 'description': 'LDL-C Responders by visit and by risk group - full analysis set (FAS)'}], 'secondaryOutcomes': [{'measure': 'Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.', 'timeFrame': 'Week 4', 'description': 'LDL-C Responders by visit and by risk group - FAS'}, {'measure': 'Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment', 'timeFrame': 'Weeks 4 and 8', 'description': 'Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride'}, {'measure': 'Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment', 'timeFrame': 'weeks 4 and 8', 'description': 'Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride'}, {'measure': 'Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.', 'timeFrame': '8 weeks', 'description': 'LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)'}, {'measure': 'Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.', 'timeFrame': '8 weeks', 'description': 'LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)'}, {'measure': 'Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment', 'timeFrame': '4 and 8 weeks', 'description': 'Median baseline, and change from baseline in hs-CRP by risk group - FAS'}, {'measure': 'Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment', 'timeFrame': '4 and 8 weeks', 'description': 'Percent change from baseline in hs-CRP by risk group - FAS'}, {'measure': 'Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.', 'timeFrame': 'Baseline, and 8 weeks', 'description': 'Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS'}, {'measure': 'Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.', 'timeFrame': '8 weeks', 'description': 'Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581157&StudyName=Lipitor%20Korean%20Atorvastatin%20Goal%20Achievement%20Across%20Risk%20Levels%20Study', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is a Korean , dyslipidemic outpatient\n2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk \\< 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk \\> 20 %)\n3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline\n\nExclusion Criteria:\n\n1. Is pregnant or lactating\n2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis\n3. Has history of intolerance or hypersensitivity to atorvastatin or other statins\n4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)\n5. Has HbAlc \\> 10%\n6. Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)'}, 'identificationModule': {'nctId': 'NCT00540293', 'acronym': 'AT GOAL', 'briefTitle': 'Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Eight-Week Treatment, Single-Step Titration Open-Label Study Assessing The Percentage Of Korean Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 MG, 20 MG, And 40 MG.', 'orgStudyIdInfo': {'id': 'A2581157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'this patient group consists of dyslipidemia patients with various CVD risk factors', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '705-717', 'city': 'Daegu', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '135-710', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '602-739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-718', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '503-715', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '431-070', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '463-707', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '420-717', 'city': 'Kyunggi-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site'}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-746', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-010', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-914', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}