Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01569867
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2012-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic Influences on Statin Blood Concentrations in African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Frozen plasma and frozen nuclear pellet'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour area under the time-concentration curve of statin concentrations in plasma', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of statin-associated muscle symptoms (SAMS)', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Hypercholesterolemia', 'Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '25612772', 'type': 'BACKGROUND', 'citation': 'Wang J, Luzum JA, Phelps MA, Kitzmiller JP. Liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of simvastatin, lovastatin, atorvastatin, and their major metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Mar 1;983-984:18-25. doi: 10.1016/j.jchromb.2014.12.029. Epub 2015 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in African-American patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin)\n\nExclusion Criteria:\n\n* Age less than 18 years'}, 'identificationModule': {'nctId': 'NCT01569867', 'briefTitle': 'Genetic Influences on Statin Blood Concentrations in African Americans', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'An Observational Study Investigating Genetic Influences on Statin Plasma Concentrations in Adult African American Patients', 'orgStudyIdInfo': {'id': 'OSU 2011H0402'}, 'secondaryIdInfos': [{'id': 'K23GM100372', 'link': 'https://reporter.nih.gov/quickSearch/K23GM100372', 'type': 'NIH'}, {'id': 'R01MD011307', 'link': 'https://reporter.nih.gov/quickSearch/R01MD011307', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'statin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Joseph P Kitzmiller, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sakima Smith', 'investigatorAffiliation': 'Ohio State University'}}}}