Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-01 @ 3:25 PM
Study NCT ID:
NCT00815659
Status:
COMPLETED
Last Update Posted:
2011-08-31
First Post:
2008-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks', 'otherNumAtRisk': 97, 'otherNumAffected': 29, 'seriousNumAtRisk': 97, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CK Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pruritus-Allergy-Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dermatoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eye Twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leg Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leg Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough-Dry Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Liver Function Tests Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Basal HDL-cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'spread': '9.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) HDL levels of participants'}, {'type': 'PRIMARY', 'title': 'Basal LDL-cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '165.5', 'spread': '32.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline LDL levels of participants'}, {'type': 'PRIMARY', 'title': 'LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'spread': '44.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) LDL levels of participants'}, {'type': 'PRIMARY', 'title': 'Basal Total Cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '236.5', 'spread': '38.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)', 'description': 'Baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline total cholesterol levels of participants'}, {'type': 'PRIMARY', 'title': 'Total Cholesterol Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '166.2', 'spread': '47.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) total cholesterol levels of participants'}, {'type': 'PRIMARY', 'title': 'Basal Triglyceride Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '195.1', 'spread': '65.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline triglyceride levels of participants'}, {'type': 'PRIMARY', 'title': 'Triglyceride Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '153.1', 'spread': '76.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) triglyceride levels of participants'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \\<100 mg/dL; HDL-cholesterol: For males \\>40 mg/dL, for females \\>50 mg/dL; non-HDL-cholesterol: \\<130 mg/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LDL cholesterol levels \\< 100 mg/dL, calculated over patients with lipid measurement performed at both visits'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'HDL cholesterol target levels for males \\>40 mg/dL, for females \\> 50 mg/dL, calculated over patients with lipid measurement performed at both visits'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-HDL cholesterol target levels \\<130 mg/dL, calculated over patients with lipid measurement performed at both visits'}, {'type': 'SECONDARY', 'title': 'Basal Interleukin 1 (IL-1) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'IL-1 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline IL-1 levels of participants'}, {'type': 'SECONDARY', 'title': 'Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) IL-1 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal Interleukin 6 (IL-6) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'IL-6 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline IL-6 levels of participants'}, {'type': 'SECONDARY', 'title': 'Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) IL-6 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal Interleukin 8 (IL-8) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '5.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'IL-8 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline IL-8 levels of participants'}, {'type': 'SECONDARY', 'title': 'Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '13.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) IL-8 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal Interleukin 10 (IL-10) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'IL-10 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline IL-10 levels of participants'}, {'type': 'SECONDARY', 'title': 'Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '3.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) IL-10 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal Tumor Necrosis Factor (TNF) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'TNF levels before (Visit 2-enrollment)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Basal Tumor Necrosis Factor (TNF) levels of participants'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '9.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal High Sensitivity C-reactive Protein (Hs-CRP) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'hs-CRP levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants'}, {'type': 'SECONDARY', 'title': 'High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal LDL-3 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'spread': '9.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline LDL-3 levels of participants'}, {'type': 'SECONDARY', 'title': 'LDL-3 Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) LDL-3 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal LDL-4 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'LDL-4 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline LDL-4 levels of participants'}, {'type': 'SECONDARY', 'title': 'LDL-4 Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF(Last Observation Carried Forward) LDL-4 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal LDL-5 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '7.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'LDL-5 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline LDL-5 levels of participants'}, {'type': 'SECONDARY', 'title': 'LDL-5 Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) LDL-5 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal LDL-6 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'LDL-6 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline LDL-6 levels of participants'}, {'type': 'SECONDARY', 'title': 'LDL-6 Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) LDL-6 levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal LDL-7 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'LDL-7 levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline LDL-7 levels of participants'}, {'type': 'SECONDARY', 'title': 'LDL-7 Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; 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LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal Intermediate HDL Subfraction Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Intermediate HDL subfraction levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Intermediate HDL subfraction of participants'}, {'type': 'SECONDARY', 'title': 'Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants'}, {'type': 'SECONDARY', 'title': 'Basal Small HDL Subfraction Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Small HDL subfraction levels before (Visit 2-enrollment)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Small HDL subfraction of participants'}, {'type': 'SECONDARY', 'title': 'Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '4.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients with any adverse events in 3 months of rosuvastatin treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with any adverse events in 3 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Crestor', 'description': 'Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2008-12-29', 'resultsFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2008-12-29', 'lastUpdatePostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-07', 'studyFirstPostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basal HDL-cholesterol Level', 'timeFrame': 'Baseline', 'description': 'HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)'}, {'measure': 'HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal LDL-cholesterol Level', 'timeFrame': 'Baseline', 'description': 'LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)'}, {'measure': 'LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Total Cholesterol Level', 'timeFrame': 'Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)', 'description': 'Baseline'}, {'measure': 'Total Cholesterol Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Triglyceride Level', 'timeFrame': 'Baseline', 'description': 'Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)'}, {'measure': 'Triglyceride Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \\<100 mg/dL; HDL-cholesterol: For males \\>40 mg/dL, for females \\>50 mg/dL; non-HDL-cholesterol: \\<130 mg/dL'}, {'measure': 'Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment'}, {'measure': 'Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment'}], 'secondaryOutcomes': [{'measure': 'Basal Interleukin 1 (IL-1) Level', 'timeFrame': 'Baseline', 'description': 'IL-1 levels before (Visit 2-enrollment)'}, {'measure': 'Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Interleukin 6 (IL-6) Level', 'timeFrame': 'Baseline', 'description': 'IL-6 levels before (Visit 2-enrollment)'}, {'measure': 'Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Interleukin 8 (IL-8) Level', 'timeFrame': 'Baseline', 'description': 'IL-8 levels before (Visit 2-enrollment)'}, {'measure': 'Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Interleukin 10 (IL-10) Level', 'timeFrame': 'Baseline', 'description': 'IL-10 levels before (Visit 2-enrollment)'}, {'measure': 'Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Tumor Necrosis Factor (TNF) Level', 'timeFrame': 'Baseline', 'description': 'TNF levels before (Visit 2-enrollment)'}, {'measure': 'Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal High Sensitivity C-reactive Protein (Hs-CRP) Level', 'timeFrame': 'Baseline', 'description': 'hs-CRP levels before (Visit 2-enrollment)'}, {'measure': 'High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal LDL-3 Level', 'timeFrame': 'Baseline', 'description': 'LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls'}, {'measure': 'LDL-3 Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal LDL-4 Level', 'timeFrame': 'Baseline', 'description': 'LDL-4 levels before (Visit 2-enrollment)'}, {'measure': 'LDL-4 Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal LDL-5 Level', 'timeFrame': 'Baseline', 'description': 'LDL-5 levels before (Visit 2-enrollment)'}, {'measure': 'LDL-5 Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal LDL-6 Level', 'timeFrame': 'Baseline', 'description': 'LDL-6 levels before (Visit 2-enrollment)'}, {'measure': 'LDL-6 Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal LDL-7 Level', 'timeFrame': 'Baseline', 'description': 'LDL-7 levels before (Visit 2-enrollment)'}, {'measure': 'LDL-7 Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Large HDL Subfraction Level', 'timeFrame': 'Baseline', 'description': 'Large HDL subfraction levels before (Visit 2-enrollment)'}, {'measure': 'Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Intermediate HDL Subfraction Level', 'timeFrame': 'Baseline', 'description': 'Intermediate HDL subfraction levels before (Visit 2-enrollment)'}, {'measure': 'Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Basal Small HDL Subfraction Level', 'timeFrame': 'Baseline', 'description': 'Small HDL subfraction levels before (Visit 2-enrollment)'}, {'measure': 'Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)'}, {'measure': 'Number of Patients With Adverse Events', 'timeFrame': '3 months (from enrollment to last visit)', 'description': 'Number of patients with any adverse events in 3 months of rosuvastatin treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plasma lipid profile', 'metabolic syndrome'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)\n* LDL-Cholesterol \\> 130mg/dl\n* HDL-Cholesterol \\< 40mg/dl in males and \\<50mg/dl in females\n* Triglycerides \\< 400 mg/dl\n\nExclusion Criteria:\n\n* With a concomitant coronary disease\n* Currently under statin therapy or previously treated with statins within the last 6 months'}, 'identificationModule': {'nctId': 'NCT00815659', 'acronym': 'EFFORT', 'briefTitle': 'Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)', 'orgStudyIdInfo': {'id': 'D3560L00079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'description': 'medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.', 'interventionNames': ['Drug: rosuvastatin']}], 'interventions': [{'name': 'rosuvastatin', 'type': 'DRUG', 'otherNames': ['CRESTOR'], 'description': 'medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.', 'armGroupLabels': ['Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Besevler', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Kayseri', 'state': 'Erciyes', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'city': 'Istanbul', 'state': 'Haseki', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Kocaeli', 'state': 'Umuttepe', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Dilek Ural, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University Faculty of Medicine Cardiology Dept'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}