Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-19 @ 11:36 PM
Study NCT ID:
NCT00874757
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'trmcguir@unmc.edu', 'phone': '402-651-2496', 'title': 'Timothy R McGuire', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Collected over 3 weeks for each subject', 'eventGroups': [{'id': 'EG000', 'title': 'Rosuvastatin', 'description': 'Single arm non-therapeutic study', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Toll-like Receptor 4 Expression Pre- and Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-treatment Tlr-4 Expression', 'description': 'Whole blood collected analyzed by flow cytometry prior to the start of rosuvastatin'}, {'id': 'OG001', 'title': 'Post-treatment Trl-4 Monocyte Expression', 'description': 'Flow cytometry performed on blood after 3 weeks of treatment with rosuvastatin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.37', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '6.36', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after three weeks of treatment with rosuvastatin', 'description': 'Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.', 'unitOfMeasure': '% tlr expression (monocytes)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 16 healthy subjects who met inclusion/exclusion criteria'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor (TNF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline (Pre-Rosuvastatin Treatment)', 'description': '16 subjects had blood collected before treatment with rosuvastatin and blood was treated with LPS ex-vivo and TNF concentrations measured.'}, {'id': 'OG001', 'title': 'Post Rosuvastatin Treatment', 'description': 'Blood samples collected were treated with Lipopolysaccharides (LPS) and tumor necrosis factor (TNF) measured'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'spread': '52', 'groupId': 'OG000'}, {'value': '92', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and post 3 weeks of rosuvastatin treatment', 'description': 'Inflammatory cytokine generated after treatment of whole blood collected before and after rosuvastatin treatment', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interleukin-6 Baseline (Before Rosuvastatin Treatment)', 'description': 'Interleukin-6 concentrations after blood treated with LPS (baseline)'}, {'id': 'OG001', 'title': 'Interleukin-6 Post-treatment', 'description': 'Interleukin-6 concentrations after blood treated with LPS after 3 weeks of rosuvastatin'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before (baseline) and after 3 weeks of rosuvastatin treatment', 'description': 'Interleukin-6 inflammatory cytokine which will be released after LPS treatment of blood', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Interleukin-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-Treatment IL-8', 'description': 'IL-8 concentrations in blood treated with LPS before treatment with rosuvastatin'}, {'id': 'OG001', 'title': 'Post-treatment IL-8', 'description': 'IL-8 concentrations in blood treated with LPS after treatment with rosuvastatin'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'spread': '45', 'groupId': 'OG000'}, {'value': '125', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment', 'description': 'Interleukin-8 an inflammatory cytokine which will be releases after LPS treatment.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '16 subjects that met the inclusion/exclusion criteria the pre-post analysis allowed the use of paired T-test'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rosuvastatin', 'description': '20 subjects were consented to receive rosuvastatin 20 mg tablets orally every day for three weeks. 16 of the 20 received study drug with four being excluded due to baseline laboratory abnormalities.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Institutional review board (IRB) approved consents on 11-11-2010 with first subject consented on 11-15-2010', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'While 20 subjects were consented 3 subjects were excluded from receiving rosuvastatin based on elevated liver function tests and 1 subject based on elevated creatine kinase.', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Baseline laboratories outside of normal limits (screen fails).', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A total of 20 subjects were consented between 11/15/2010 and on 8/4/2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rosuvastatin', 'description': 'Single arm non-therapeutic study where all subjects who ruled in for study participation (based on baseline laboratories and clinical assessment) received rosuvastatin 20 mg tablets for three weeks. Inflammatory markers Toll-like Receptor 4, tumor necrosis factor, Interleukin 6, Interleukin 8 (tlr-4, TNF, IL-6, IL-8) were measured at baseline prior to rosuvastatin administration and after treatment to compare the effect of rosuvastatin on inflammatory markers. The primary outcome was the %tlr positive monocytes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The 16 patients that met inclusion/exclusion criteria were Caucasian.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2011-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2009-04-01', 'resultsFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-28', 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toll-like Receptor 4 Expression Pre- and Post-Treatment', 'timeFrame': 'Before and after three weeks of treatment with rosuvastatin', 'description': 'Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.'}], 'secondaryOutcomes': [{'measure': 'Tumor Necrosis Factor (TNF)', 'timeFrame': 'Pre and post 3 weeks of rosuvastatin treatment', 'description': 'Inflammatory cytokine generated after treatment of whole blood collected before and after rosuvastatin treatment'}, {'measure': 'Interleukin-6', 'timeFrame': 'Before (baseline) and after 3 weeks of rosuvastatin treatment', 'description': 'Interleukin-6 inflammatory cytokine which will be released after LPS treatment of blood'}, {'measure': 'Interleukin-8', 'timeFrame': 'measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment', 'description': 'Interleukin-8 an inflammatory cytokine which will be releases after LPS treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Statins, anti-inflammatory', 'Healthy subjects study'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '16614188', 'type': 'BACKGROUND', 'citation': 'Wickelgren I. Immunology. Targeting the tolls. Science. 2006 Apr 14;312(5771):184-7. doi: 10.1126/science.312.5771.184. No abstract available.'}, {'pmid': '18263570', 'type': 'BACKGROUND', 'citation': 'Falagas ME, Makris GC, Matthaiou DK, Rafailidis PI. Statins for infection and sepsis: a systematic review of the clinical evidence. J Antimicrob Chemother. 2008 Apr;61(4):774-85. doi: 10.1093/jac/dkn019. Epub 2008 Feb 7.'}, {'pmid': '16443229', 'type': 'BACKGROUND', 'citation': 'Niessner A, Steiner S, Speidl WS, Pleiner J, Seidinger D, Maurer G, Goronzy JJ, Weyand CM, Kopp CW, Huber K, Wolzt M, Wojta J. Simvastatin suppresses endotoxin-induced upregulation of toll-like receptors 4 and 2 in vivo. Atherosclerosis. 2006 Dec;189(2):408-13. doi: 10.1016/j.atherosclerosis.2005.12.022. Epub 2006 Jan 26.'}, {'pmid': '19205663', 'type': 'BACKGROUND', 'citation': 'Novack V, Eisinger M, Frenkel A, Terblanche M, Adhikari NK, Douvdevani A, Amichay D, Almog Y. The effects of statin therapy on inflammatory cytokines in patients with bacterial infections: a randomized double-blind placebo controlled clinical trial. Intensive Care Med. 2009 Jul;35(7):1255-60. doi: 10.1007/s00134-009-1429-0. Epub 2009 Feb 11.'}, {'pmid': '18068482', 'type': 'BACKGROUND', 'citation': 'Wang CY, Liu PY, Liao JK. Pleiotropic effects of statin therapy: molecular mechanisms and clinical results. Trends Mol Med. 2008 Jan;14(1):37-44. doi: 10.1016/j.molmed.2007.11.004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The investigators will study this potential anti-inflammatory activity in healthy subjects.', 'detailedDescription': 'After providing consent healthy subjects (N=20) completed a health and drug inventory questionnaire and had blood samples drawn to measure baseline electrolytes, kidney function, liver function, and creatine kinase to determine study eligibility. Blood samples were also collected to analyze baseline inflammatory markers (tlr-4 monocyte expression and cytokine production). Patients received 20 mg daily of rosuvastatin for 3 weeks followed by blood collection, and the measurement of inflammatory markers repeated. Whole blood samples were analyzed by flow-cytometry to determine percent expression of tlr-4 on monocytes which was the primary inflammatory marker for the study. Secondary inflammatory markers tumor necrosis factor (TNF), interleukin-6 (IL-6), and interleukin-8 (IL-8) were measured after blood was incubated ex-vivo with lipopolysaccharide (LPS) for 3 hours. LPS induction experiments were performed on blood from pre and post rosuvastatin treatment. Finally, blood lipid profiles (cholesterol, low density lipoprotein (LDL), very low-density lipoprotein (VLDL), and high density lipo protein (HDL), were assessed both pre and post rosuvastatin treatment. End of study (after 3 weeks of rosuvastatin treatment) electrolytes, kidney function, liver function, and creatine kinase (CK) were measured to determine any changes as a result of rosuvastatin treatment. In addition to pre and post safety assessment a phone call was made to evaluate rosuvastatin side effects at the midpoint of the three-week treatment period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male non-asian subjects\n\nExclusion Criteria:\n\n* Patients with increased liver function tests, elevated serum creatine, patients on anti-inflammatory or immunomodulating drugs'}, 'identificationModule': {'nctId': 'NCT00874757', 'briefTitle': 'Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of', 'orgStudyIdInfo': {'id': '0088-09-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rosuvastatin', 'description': 'Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre and post rosuvastatin treatment.', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre- and post- rosuvastatin treatment.', 'armGroupLabels': ['Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-6045', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center, College of Pharmacy', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Timothy R McGuire, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}