Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-09 @ 7:05 PM
Study NCT ID:
NCT01732718
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2012-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000419', 'term': 'Albuminuria'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kataga@uthsc.edu', 'phone': '901-448-2813', 'title': 'Kenneth Ataga, MD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was limited by its small sample size.'}}, 'adverseEventsModule': {'timeFrame': 'Beginning with the first intervention and throughout washout and second intervention and then for 4 weeks after end of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Influenza B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches/Head Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain Crisis Treated at Home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema of Lower Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low O2 Saturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Axillary Adenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Wrist Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pain Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Palpitations and Fainting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in Endothelial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'groupId': 'OG000', 'lowerLimit': '-2.66', 'upperLimit': '4.43'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '-1.94', 'upperLimit': '3.18'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Endothelial function will be assessed using ultrasound imaging of the brachial artery, with measurement of endothelium-dependent (flow-mediated) and endothelium-independent (nitroglycerin-mediated) dilation of the artery measured in millimeters (mm).', 'unitOfMeasure': '% diameter change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '22.99', 'groupId': 'OG000', 'lowerLimit': '-58.8', 'upperLimit': '41.7'}, {'value': '7.54', 'groupId': 'OG001', 'lowerLimit': '-75.2', 'upperLimit': '149.9'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will measure plasma levels of soluble vascular cell adhesion molecules (sVCAM) and soluble intracellular adhesion molecule (sICAM) at baseline and at 6 weeks of treatment.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Investigators elected to look at only one marker of vascular endothelial injury, i.e. sVCAM, so there is no data for sICAM.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Heme Oxygenase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'timeFrame': 'Baseline, 6 weeks', 'description': 'The expression and activity of heme oxygenase-1(HO-1)will be determined at baseline and at 6 weeks of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '-47.1', 'upperLimit': '47.7'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '-20.9', 'upperLimit': '129.6'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will measure plasma levels of soluble fms-like tyrosine kinase-1 (sFLT-1) at baseline and at 6 weeks of treatment.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Monocyte Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry performed to assess monocyte activation at baseline and at 6 weeks of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '-28.6', 'upperLimit': '237.1'}, {'value': '74.9', 'groupId': 'OG001', 'lowerLimit': '-15.2', 'upperLimit': '373.4'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'see comments for explanation', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will assess the effect of atorvastatin on albuminuria by spot urine microalbuminuria/creatinine ratio measured at baseline and at 6 weeks of treatment.', 'unitOfMeasure': 'ug per mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously from randomization through end of study', 'description': 'Subjects will be evaluated for safety by patient self-report of adverse events and results of laboratory tests.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Abnormal Physical Findings.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline-Atorvastatin', 'description': 'Participants receiving Atorvastatin 40 mg tablets once daily for 6 weeks'}, {'id': 'OG001', 'title': 'Week 4-Atorvastatin', 'description': 'Participants receiving Atorvastatin 40 mg tablets once daily for 6 weeks'}, {'id': 'OG002', 'title': 'Week 6-Atorvastatin', 'description': 'Participants receiving Atorvastatin 40 mg tablets once daily for 6 weeks'}, {'id': 'OG003', 'title': 'Baseline-Placebo', 'description': 'Participants receiving Placebo once daily for 6 weeks'}, {'id': 'OG004', 'title': 'Week 4-Placebo', 'description': 'Participants receiving Placebo once daily for 6 weeks'}, {'id': 'OG005', 'title': 'Week 6-Placebo', 'description': 'Participants receiving Placebo once daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2, 4, and 6 weeks during treatment, and at follow-up.', 'description': 'Subjects will be evaluated by physical examination and/or measurement of vital signs at each study visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Rho/Rho Kinase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'timeFrame': 'Baseline, 6 weeks', 'description': 'The expression and activity of rho/rho kinase will be determined at baseline and at 6 weeks of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to loss of key study personnel these data were not collected'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Plasma Levels of Vascular Endothelial Growth Factor (VEGF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.99', 'groupId': 'OG000', 'lowerLimit': '-29.4', 'upperLimit': '7.8'}, {'value': '-10.5', 'groupId': 'OG001', 'lowerLimit': '-50.4', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will measure plasma levels of vascular endothelial growth factor (VEGF) at baseline and at 6 weeks of treatment.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 6 in Absolute Cell Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'title': 'AMC', 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '0.12'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.41'}]}]}, {'title': 'ALC', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '0.49'}, {'value': '-0.22', 'groupId': 'OG001', 'lowerLimit': '-0.85', 'upperLimit': '0.42'}]}]}, {'title': 'ANC', 'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '0.61'}, {'value': '-0.55', 'groupId': 'OG001', 'lowerLimit': '-1.91', 'upperLimit': '0.81'}]}]}], 'analyses': [{'pValue': '0.1469', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the change in AMC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2382', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the change in ALC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5833', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the change in ANC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry will be performed to assess absolute cell counts at baseline and at 6 weeks of treatment.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent was to perform analysis using flow cytometry but cells did not survive thawing. Decision was made to use CBC laboratory values for absolute monocyte (AMC), lymphocyte (ALC) and neutrophil (ANC) counts to perform the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Tissue Factor (TF) Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry will be performed to assess TF expression at baseline and at 6 weeks of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in TF-mediated sFLT Release From Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry will be performed to assess TF-mediated sFLT release from monocytes at baseline and at 6 weeks of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 in Tricuspid Regurgitant (TR) Jet.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin', 'description': 'Participants who received Atorvastatin 40 mg tablet in either the first or the second intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Atorvastatin 40 mg) in either the first or the second intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '3.24'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.69', 'upperLimit': '0.56'}]}]}], 'analyses': [{'pValue': '0.5184', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Echocardiogram will be used to assess TR jet before and after treatment.', 'unitOfMeasure': 'm/sec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atorvastatin, Then Placebo', 'description': 'Participants first received Atorvastatin 40 mg tablets once daily for 6 weeks. After a washout period of 4 weeks, they then received placebo (matching Atorvastatin 40 mg tablets) once daily for 6 weeks.\n\nAtorvastatin: 40 mg tablet by mouth daily for 6 weeks\n\nPlacebo: Matching placebo tablet by mouth daily for 6 weeks'}, {'id': 'FG001', 'title': 'Placebo, Then Atorvastatin', 'description': 'Participants first received Placebo (matching Atorvastatin 40 mg tablets) once daily for 6 weeks. After a washout period of 4 weeks, they then received Atorvastatin 40 mg tablets once daily for 6 weeks.\n\nAtorvastatin: 40 mg tablet by mouth daily for 6 weeks\n\nPlacebo: Matching placebo tablet by mouth daily for 6 weeks'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants who were randomized to receive either Atorvastatin 40 mg or Placebo (matching Atorvastatin 40 mg)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '54'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-13', 'size': 788968, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-14T11:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2012-11-09', 'resultsFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-14', 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in Endothelial Function', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Endothelial function will be assessed using ultrasound imaging of the brachial artery, with measurement of endothelium-dependent (flow-mediated) and endothelium-independent (nitroglycerin-mediated) dilation of the artery measured in millimeters (mm).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will measure plasma levels of soluble vascular cell adhesion molecules (sVCAM) and soluble intracellular adhesion molecule (sICAM) at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Heme Oxygenase Activity', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The expression and activity of heme oxygenase-1(HO-1)will be determined at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will measure plasma levels of soluble fms-like tyrosine kinase-1 (sFLT-1) at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Monocyte Activation', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry performed to assess monocyte activation at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Renal Function', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will assess the effect of atorvastatin on albuminuria by spot urine microalbuminuria/creatinine ratio measured at baseline and at 6 weeks of treatment.'}, {'measure': 'Occurrence of Adverse Events.', 'timeFrame': 'Continuously from randomization through end of study', 'description': 'Subjects will be evaluated for safety by patient self-report of adverse events and results of laboratory tests.'}, {'measure': 'Abnormal Physical Findings.', 'timeFrame': 'Baseline, 2, 4, and 6 weeks during treatment, and at follow-up.', 'description': 'Subjects will be evaluated by physical examination and/or measurement of vital signs at each study visit.'}, {'measure': 'Change From Baseline to Week 6 in Rho/Rho Kinase Activity', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The expression and activity of rho/rho kinase will be determined at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Plasma Levels of Vascular Endothelial Growth Factor (VEGF)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigators will measure plasma levels of vascular endothelial growth factor (VEGF) at baseline and at 6 weeks of treatment.'}, {'measure': 'Mean Change From Baseline to Week 6 in Absolute Cell Counts', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry will be performed to assess absolute cell counts at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Tissue Factor (TF) Expression', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry will be performed to assess TF expression at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in TF-mediated sFLT Release From Monocytes', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Flow cytometry will be performed to assess TF-mediated sFLT release from monocytes at baseline and at 6 weeks of treatment.'}, {'measure': 'Change From Baseline to Week 6 in Tricuspid Regurgitant (TR) Jet.', 'timeFrame': 'Baseline, Week 6', 'description': 'Echocardiogram will be used to assess TR jet before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sickle cell disease', 'endothelial function', 'albuminuria', 'atorvastatin', 'soluble fms-like tyrosine kinase-1'], 'conditions': ['Sickle Cell Disease', 'Sickle Cell Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn about the effect of the drug, atorvastatin, on blood vessels in patients with sickle cell disease.\n\nThe primary hypothesis is that endothelial dysfunction is an important contributor to the pathophysiology of albuminuria in SCD. The investigators propose that atorvastatin will improve endothelial dysfunction, decrease levels of soluble fms-like tyrosine kinase-1 (sFLT-1), and decrease albuminuria in SCD patients.\n\nParticipants will be individuals with sickle cell disease, age 18 to 60, who have some degree of albuminuria. A total of 19 subjects, males and females, will be enrolled. The study is made up of Screening, Treatment, and Follow Up phases and has a cross-over design. After patients are screened for eligibility, they will be randomized to receive atorvastatin or placebo in the initial six-week treatment period. When that is complete, there will be a four-week washout period before they begin another six-week treatment period. In the second treatment period, they "cross-over" to the other treatment arm. Four weeks after the end of the second treatment period, follow-up safety assessments will be done.', 'detailedDescription': 'It is well recognized that sickle cell disease (SCD) is characterized by a vasculopathy, with involvement of multiple organs including the brain, lung, spleen, and kidney. This results in multiple clinical complications, including ischemic stroke, pulmonary hypertension, autosplenectomy, as well as albuminuria and chronic renal disease. Several recent studies have confirmed the association of both albuminuria and renal dysfunction with echocardiographically-defined pulmonary hypertension and other vasculopathic complications in SCD, suggesting that they may share a similar pathophysiology. Despite the high prevalence of albuminuria in patients with SCD and the known association of renal failure with increased mortality, the pathophysiology and treatment of albuminuria in this setting remain poorly defined.\n\nThe treatment options for nephropathy in SCD are limited. Although Angiotensin converting enzyme (ACE) inhibitors are the "standard of care" in the treatment of patients with proteinuria, there are to date no controlled, long-term studies confirming their efficacy and safety in this setting.\n\nIn this study, the investigators will evaluate the efficacy and safety of atorvastatin in SCD patients. At the completion of this trial, the investigators will have an improved understanding of the contribution of endothelial dysfunction to the pathophysiology of albuminuria in SCD. If the data support the hypothesis that atorvastatin is safe and effective in this population, the investigators plan on carrying out adequately powered studies to more definitively evaluate its safety and efficacy in the treatment and/or prevention of albuminuria in SCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sickle cell anemia (HbSS) or Sickle-beta0 thalassemia (HbS-beta0thal) between ages of 18 and 60;\n2. albuminuria (micro- or macroalbuminuria, defined as =/\\> 30mg/g creatinine);\n3. serum alanine aminotransferase (ALT) \\</= 2 times upper limits of normal and/or gamma-glutamyl transferase (GGT) \\</= 3 times upper limits of normal;\n4. platelet count \\> 150,000 cu/mm;\n5. normal baseline coagulation profile (PT, International Normalized Ratio (INR), and PTT);\n6. non-crisis, steady state with no severe pain episodes during the preceding 4 weeks, and no documented infection in the 2 weeks prior to enrollment;\n7. ability to understand the requirements of the study;\n8. if a woman of childbearing potential, must use an adequate method of contraception; and\n9. if receiving hydroxyurea, ACE inhibitors or angiotensin blockers (ARB), should be on a stable dose for at least 3 months.\n\nExclusion Criteria:\n\n1. hypersensitivity to any component of atorvastatin, or history of adverse reaction to statins;\n2. pregnant or breastfeeding;\n3. on statin therapy;\n4. history of metastatic cancer;\n5. current history of alcohol abuse;\n6. history of diabetes mellitus or poorly controlled systemic hypertension;\n7. end-stage renal disease;\n8. total cholesterol level \\< 80 mg/dL and LDL cholesterol \\> 130 mg/dL;\n9. on a chronic transfusion program;\n10. ingested any investigational drugs within the past 4 weeks;\n11. prior history of any myopathy;\n12. allergy to nitroglycerin;\n13. taking any of the following drugs: phosphodiesterase-5 inhibitors (e.g., sildenafil), cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g., cyclosporine, protease inhibitors), macrolide antibiotics (e.g., clarithromycin, erythromycin), fibric acid derivatives (e.g. gemfibrozil), niacin, colchicines, antifungal agents (azole derivatives), amiodarone, danazol, daptomycin, diltiazem, verapamil, eltrombopag, everolimus, fosphenytoin, or lanthanum.\n\nPatients will also be encouraged to avoid grape fruit juice and red yeast rice for the duration of the study.\n\nAtorvastatin is contraindicated during pregnancy and breast-feeding.'}, 'identificationModule': {'nctId': 'NCT01732718', 'acronym': 'ENDO', 'briefTitle': 'Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'The Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease (in the Grant Entitled: Endothelial Dysfunction in the Pathogenesis of Sickle Cell Nephropathy)', 'orgStudyIdInfo': {'id': '11-1354'}, 'secondaryIdInfos': [{'id': 'R01HL111659', 'link': 'https://reporter.nih.gov/quickSearch/R01HL111659', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atorvastatin, then Placebo', 'description': 'Participants first received Atorvastatin 40 mg tablets once daily for 6 weeks. After a washout period of 4 weeks, they then received placebo (matching Atorvastatin 40 mg tablets) once daily for 6 weeks.', 'interventionNames': ['Drug: Atorvastatin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Then Atorvastatin', 'description': 'Participants first received Placebo (matching Atorvastatin 40 mg tablets) once daily for 6 weeks. After a washout period of 4 weeks, they then received Atorvastatin 40 mg tablets once daily for 6 weeks.', 'interventionNames': ['Drug: Atorvastatin', 'Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor®'], 'description': '40 mg tablet by mouth daily for 6 weeks', 'armGroupLabels': ['Atorvastatin, then Placebo', 'Placebo, Then Atorvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill manufactured to mimic atorvastatin 40 mg tablet'], 'description': 'Matching placebo tablet by mouth daily for 6 weeks', 'armGroupLabels': ['Atorvastatin, then Placebo', 'Placebo, Then Atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC School of Medicine Clinical&Translational Research Ctr', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Kenneth I Ataga, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Caroina at Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}