Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-03 @ 2:21 PM
Study NCT ID:
NCT00703261
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2008-06-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
Sponsor:
Organization:
Raw JSON
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Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '10 mg Atorvastatin', 'description': 'Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.', 'otherNumAtRisk': 42, 'otherNumAffected': 4, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '80 mg Atorvastatin', 'description': 'Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.', 'otherNumAtRisk': 41, 'otherNumAffected': 8, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood Creatinine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Atorvastatin', 'description': 'Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': '80 mg Atorvastatin', 'description': 'Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '5.3'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '9.5'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'Constrained longitudinal data analysis (cLDA)', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.277', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '9.6', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.', 'unitOfMeasure': 'Percent reduction', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all participants who completed the study and had complete image sets with usable data.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Statin-Naive Participants', 'description': 'Participants self-administered one 10 mg or 80 mg atorvastatin tablet and one matching 80 mg or 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '6.5'}]}]}], 'analyses': [{'pValue': '0.195', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.', 'unitOfMeasure': 'Percent reduction', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all statin-naive participants who completed the study and had complete image sets.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 mg Atorvastatin', 'description': 'Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': '80 mg Atorvastatin', 'description': 'Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '10 mg Atorvastatin', 'description': 'Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': '80 mg Atorvastatin', 'description': 'Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '9.63', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '9.24', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '9.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2008-06-19', 'resultsFirstSubmitDate': '2011-10-25', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-25', 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment', 'timeFrame': 'Baseline and Week 12', 'description': 'Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.'}], 'secondaryOutcomes': [{'measure': 'Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants', 'timeFrame': 'Baseline and Week 12', 'description': 'Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.'}]}, 'conditionsModule': {'conditions': ['Atherosclerotic Vascular Disease']}, 'referencesModule': {'references': [{'pmid': '27956407', 'type': 'DERIVED', 'citation': 'Singh P, Emami H, Subramanian S, Maurovich-Horvat P, Marincheva-Savcheva G, Medina HM, Abdelbaky A, Alon A, Shankar SS, Rudd JH, Fayad ZA, Hoffmann U, Tawakol A. Coronary Plaque Morphology and the Anti-Inflammatory Impact of Atorvastatin: A Multicenter 18F-Fluorodeoxyglucose Positron Emission Tomographic/Computed Tomographic Study. Circ Cardiovasc Imaging. 2016 Dec;9(12):e004195. doi: 10.1161/CIRCIMAGING.115.004195.'}, {'pmid': '24070911', 'type': 'DERIVED', 'citation': 'Subramanian S, Emami H, Vucic E, Singh P, Vijayakumar J, Fifer KM, Alon A, Shankar SS, Farkouh M, Rudd JHF, Fayad ZA, Van Dyke TE, Tawakol A. High-dose atorvastatin reduces periodontal inflammation: a novel pleiotropic effect of statins. J Am Coll Cardiol. 2013 Dec 24;62(25):2382-2391. doi: 10.1016/j.jacc.2013.08.1627. Epub 2013 Sep 24.'}, {'pmid': '23727083', 'type': 'DERIVED', 'citation': 'Tawakol A, Fayad ZA, Mogg R, Alon A, Klimas MT, Dansky H, Subramanian SS, Abdelbaky A, Rudd JH, Farkouh ME, Nunes IO, Beals CR, Shankar SS. Intensification of statin therapy results in a rapid reduction in atherosclerotic inflammation: results of a multicenter fluorodeoxyglucose-positron emission tomography/computed tomography feasibility study. J Am Coll Cardiol. 2013 Sep 3;62(10):909-17. doi: 10.1016/j.jacc.2013.04.066. Epub 2013 May 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female ages 30 to 80\n* Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening\n\nExclusion Criteria:\n\n* Participant has human immunodeficiency virus (HIV), Hepatitis B or C\n* Participant uses illegal drugs\n* Participant has Type I diabetes\n* Participant has a history of claustrophobia'}, 'identificationModule': {'nctId': 'NCT00703261', 'briefTitle': 'Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease', 'orgStudyIdInfo': {'id': '0000-081'}, 'secondaryIdInfos': [{'id': '2007_651'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 mg Atorvastatin', 'description': '10 mg atorvastatin + placebo', 'interventionNames': ['Drug: atorvastatin', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '80 mg Atorvastatin', 'description': '80 mg atorvastatin + placebo', 'interventionNames': ['Drug: atorvastatin', 'Drug: placebo']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.', 'armGroupLabels': ['10 mg Atorvastatin', '80 mg Atorvastatin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.', 'armGroupLabels': ['10 mg Atorvastatin', '80 mg Atorvastatin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}