Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00683618
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2008-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily', 'otherNumAtRisk': 145, 'otherNumAffected': 5, 'seriousNumAtRisk': 145, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily', 'otherNumAtRisk': 145, 'otherNumAffected': 3, 'seriousNumAtRisk': 145, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily', 'otherNumAtRisk': 146, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Alanine Aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 146, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 146, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 146, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 146, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 146, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.70', 'spread': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.62'}, {'value': '-38.67', 'spread': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.28', 'spread': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.62'}, {'value': '-38.67', 'spread': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.63', 'spread': '2.29', 'groupId': 'OG000', 'lowerLimit': '2.29'}, {'value': '6.82', 'spread': '2.29', 'groupId': 'OG001', 'lowerLimit': '2.29'}, {'value': '3.64', 'spread': '2.31', 'groupId': 'OG002', 'lowerLimit': '2.31'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.62', 'spread': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.92'}, {'value': '-33.14', 'spread': '1.91', 'groupId': 'OG001', 'lowerLimit': '1.91'}, {'value': '-28.06', 'spread': '1.93', 'groupId': 'OG002', 'lowerLimit': '1.93'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Triglycerides (TG) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.09', 'spread': '4.72', 'groupId': 'OG000', 'lowerLimit': '4.72'}, {'value': '-22.05', 'spread': '4.69', 'groupId': 'OG001', 'lowerLimit': '4.69'}, {'value': '-20.67', 'spread': '4.73', 'groupId': 'OG002', 'lowerLimit': '4.73'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.60', 'spread': '3.57', 'groupId': 'OG000', 'lowerLimit': '3.57'}, {'value': '-46.08', 'spread': '3.57', 'groupId': 'OG001', 'lowerLimit': '3.57'}, {'value': '-38.50', 'spread': '3.60', 'groupId': 'OG002', 'lowerLimit': '3.60'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.55', 'spread': '2.40', 'groupId': 'OG000', 'lowerLimit': '2.40'}, {'value': '-41.21', 'spread': '2.40', 'groupId': 'OG001', 'lowerLimit': '2.40'}, {'value': '-34.67', 'spread': '2.41', 'groupId': 'OG002', 'lowerLimit': '2.41'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '1.99', 'groupId': 'OG000', 'lowerLimit': '1.99'}, {'value': '4.25', 'spread': '1.98', 'groupId': 'OG001', 'lowerLimit': '1.98'}, {'value': '1.79', 'spread': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.00'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.95', 'spread': '2.96', 'groupId': 'OG000', 'lowerLimit': '2.96'}, {'value': '-38.04', 'spread': '2.96', 'groupId': 'OG001', 'lowerLimit': '2.96'}, {'value': '-31.92', 'spread': '2.99', 'groupId': 'OG002', 'lowerLimit': '2.99'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.07', 'spread': '3.17', 'groupId': 'OG000', 'lowerLimit': '3.17'}, {'value': '-50.27', 'spread': '3.16', 'groupId': 'OG001', 'lowerLimit': '3.16'}, {'value': '-41.04', 'spread': '3.19', 'groupId': 'OG002', 'lowerLimit': '3.19'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.79', 'spread': '11.54', 'groupId': 'OG000', 'lowerLimit': '11.54'}, {'value': '-56.63', 'spread': '11.52', 'groupId': 'OG001', 'lowerLimit': '11.52'}, {'value': '-48.33', 'spread': '11.64', 'groupId': 'OG002', 'lowerLimit': '11.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.62', 'spread': '3.15', 'groupId': 'OG000', 'lowerLimit': '3.15'}, {'value': '-41.87', 'spread': '3.14', 'groupId': 'OG001', 'lowerLimit': '3.14'}, {'value': '-35.15', 'spread': '3.16', 'groupId': 'OG002', 'lowerLimit': '3.16'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '79.1', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 6', 'description': 'The percentage of patients achieved LDL-C goal is done in ITT population.\n\nNational Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:\n\nModerately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \\< 3.36mmol/L(130mg/dL), non-HDL-C goal \\< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \\>20%): LDL-C goal\\< 2.60mmol/L (100mg/dL), non-HDL-C goal \\< 3.36mmol/L (130mg/dL)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': '6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}, {'value': '60.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 6', 'description': 'The percentage of patients achieved LDL-C goal is done in ITT population.\n\nNational Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:\n\nModerately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \\< 3.36mmol/L(130mg/dL); non-HDL-C goal \\< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \\>20%): LDL-C goal\\< 2.60mmol/L (100mg/dL),non-HDL-C goal \\< 3.36mmol/L (130mg/dL)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'OG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'OG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}, {'value': '47.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from week 6 to week 12', 'description': 'The percentage of patients achieved LDL-C goal is done in ITT population.\n\nNational Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:\n\nModerately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \\< 3.36mmol/L(130mg/dL), non-HDL-C goal \\< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \\>20%): LDL-C goal\\< 2.60mmol/L (100mg/dL), non-HDL-C goal \\< 3.36mmol/L (130mg/dL)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': "Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator's discretion."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'FG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'FG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}], 'periods': [{'title': 'Randomised Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Reason not provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Extension Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In total 934 patients were enrolled to the study, the study was conducted at 13 investigational sites in China. The first patient was enrolled on 27 May 2008, the last patient was completed on 16 Jul 2009.', 'preAssignmentDetails': 'There is a dietary lead in period before randomization. 934 patients started the dietary lead in period. 436 patients completed this period. The baseline measurement is based on the ITT population. Patients included in ITT population in each arm is : Rosuvastatin 5mg 136, Rosuvastatin 10mg 139 and Atorvastatin 10mg 139.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '414', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rosuvastatin 5mg', 'description': 'Taken orally once daily'}, {'id': 'BG001', 'title': 'Rosuvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'BG002', 'title': 'Atorvastatin 10mg', 'description': 'Taken orally once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '8.51', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '10.57', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '9.29', 'groupId': 'BG002'}, {'value': '59.5', 'spread': '9.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}]}], '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'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '414', 'groupId': 'BG003'}]}]}, {'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'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Nativ Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Low density lipoprotein cholesterol (LDL-C level)', 'classes': [{'categories': [{'measurements': [{'value': '4.242', 'spread': '0.6769', 'groupId': 'BG000'}, {'value': '4.131', 'spread': '0.6818', 'groupId': 'BG001'}, {'value': '4.213', 'spread': '0.6617', 'groupId': 'BG002'}, {'value': '4.186', 'spread': '0.6717', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'triglyceride (TG) level', 'classes': [{'categories': [{'measurements': [{'value': '1.921', 'spread': '0.7825', 'groupId': 'BG000'}, {'value': '2.042', 'spread': '0.9164', 'groupId': 'BG001'}, {'value': '2.061', 'spread': '0.8971', 'groupId': 'BG002'}, {'value': '1.991', 'spread': '0.8494', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 934}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2008-05-21', 'resultsFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2008-05-22', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-08', 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Triglycerides (TG) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6', 'timeFrame': 'baseline, 6 weeks', 'description': 'Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.'}, {'measure': 'Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6', 'timeFrame': 'week 6', 'description': 'The percentage of patients achieved LDL-C goal is done in ITT population.\n\nNational Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:\n\nModerately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \\< 3.36mmol/L(130mg/dL), non-HDL-C goal \\< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \\>20%): LDL-C goal\\< 2.60mmol/L (100mg/dL), non-HDL-C goal \\< 3.36mmol/L (130mg/dL)'}, {'measure': '6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6', 'timeFrame': 'week 6', 'description': 'The percentage of patients achieved LDL-C goal is done in ITT population.\n\nNational Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:\n\nModerately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \\< 3.36mmol/L(130mg/dL); non-HDL-C goal \\< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \\>20%): LDL-C goal\\< 2.60mmol/L (100mg/dL),non-HDL-C goal \\< 3.36mmol/L (130mg/dL)'}, {'measure': 'Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration', 'timeFrame': 'from week 6 to week 12', 'description': 'The percentage of patients achieved LDL-C goal is done in ITT population.\n\nNational Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:\n\nModerately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \\< 3.36mmol/L(130mg/dL), non-HDL-C goal \\< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \\>20%): LDL-C goal\\< 2.60mmol/L (100mg/dL), non-HDL-C goal \\< 3.36mmol/L (130mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HMG-CoA', 'LDL-C', 'CHD'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '28836458', 'type': 'DERIVED', 'citation': 'Zhao S, Peng D. Efficacy and safety of rosuvastatin versus atorvastatin in high-risk Chinese patients with hypercholesterolemia: a randomized, double-blind, active-controlled study. Curr Med Res Opin. 2018 Feb;34(2):227-235. doi: 10.1080/03007995.2017.1371584. Epub 2017 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia\n* LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L\n* Fasting triglyceride less than 4.52mmol/L\n\nExclusion Criteria:\n\n* History of statin induced myopathy\n* Unstable or uncontrolled cardiovascular diseases\n* Familial dysbetalipoproteinemia'}, 'identificationModule': {'nctId': 'NCT00683618', 'briefTitle': 'Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind Trial to Compare the Efficacy of Rosuvastatin 5 and 10 mg to Atorvastatin 10 mg in the Treatment of High Risk Patients With Hypercholesterolemia Followed by an Open Label Treatment Period With Rosuvastatin Up-titrated to the Maximum Dose of 20 mg for Those Patients Who do Not Achieve Goal', 'orgStudyIdInfo': {'id': 'D356FC00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rosuvastatin 5mg qd', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Rosuvastatin 10mg qd', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Atorvastatin 10mg qd', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Capsule/Tablet, oral, qd, 6 or 12 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'Capsule/Tablet, 10mg, oral, qd, 6 weeks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Marie Eckerd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AZ Pharmaceuticals - US'}, {'name': 'Zhao Shuiping', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd hospital of Xiangya medical university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}