Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 2:58 PM
Study NCT ID:
NCT00819403
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2009-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmiller@medicine.umaryland.edu', 'phone': '410 328-6299', 'title': 'Dr Michael Miller', 'organization': 'Univ Maryland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg daily\n\nsimvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.', 'otherNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Simvastatin/Ezetimibe', 'description': 'Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.\n\nezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI symptoms', 'notes': 'Gas, bloating, change in bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle symptoms', 'notes': 'Aches, cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.'}, {'id': 'OG001', 'title': 'Simvastatin/Ezetimibe', 'description': 'Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.'}], 'classes': [{'title': 'PAR 1/4 antigen', 'categories': [{'measurements': [{'value': '35.4', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'PAR 1/4 activity', 'categories': [{'measurements': [{'value': '23.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Measured using whole blood flow cytometry', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on power calculations'}, {'type': 'SECONDARY', 'title': 'Biomarkers of Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.'}, {'id': 'OG001', 'title': 'Simvastatin/Ezetimibe', 'description': 'Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.'}], 'classes': [{'title': 'CRP', 'categories': [{'measurements': [{'value': '3.51', 'spread': '.48', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '.34', 'groupId': 'OG001'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.24', 'spread': '.12', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin Then Simvastatin/Ezetimibe', 'description': 'Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily\n\nSubjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied.'}, {'id': 'FG001', 'title': 'Simvastatin/Ezetimibe Then Simvastatin', 'description': 'Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.'}], 'periods': [{'title': 'First Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All patients have been recruited and 15 have successfully completed the study.', 'preAssignmentDetails': 'Patients excluded included those unable to tolerate statin and/or ezetimibe treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg daily\n\nsimvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.'}, {'id': 'BG001', 'title': 'Simvastatin/Ezetimibe', 'description': 'Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.\n\nezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '48.5', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2009-01-07', 'resultsFirstSubmitDate': '2013-02-27', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-10', 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression', 'timeFrame': '6 weeks', 'description': 'Measured using whole blood flow cytometry'}], 'secondaryOutcomes': [{'measure': 'Biomarkers of Inflammation', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['triglycerides', 'hypertension', 'low hdl', 'obesity'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.', 'detailedDescription': '1. To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrome.\n2. To compare platelet-related effects including PAR-1 receptor inhibition of E/S with those of the established anti-platelet agents including aspirin, clopidogrel, intravenous and oral glycoprotein IIb/IIIa inhibitors.\n3. To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women greater than or equal to 21 years of age\n2. Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:\n\n * abdominal obesity, given as waist circumference for men \\> 102 cm, and for women \\> 88 cm\n * triglycerides \\> 150 mg/dL\n * HDL cholesterol \\< 40 mg/dL for men, and \\< 50 mg/dL for women\n * blood pressure \\> 130/85 mm Hg\n * fasting glucose \\> 100 mg/dL\n\nExclusion Criteria:\n\n1. Patients will be excluded for a history of bleeding diathesis\n2. drug or alcohol abuse\n3. prothrombin time greater than 1.5 times control\n4. platelet count \\< 100,000/mm3\n5. hematocrit \\< 25%\n6. creatinine \\> 4.0 mg/dl\n7. surgery or angioplasty performed within 3 months or planned for the future\n8. history of gastrointestinal or other bleeding\n9. history of drug-induced disorders\n10. trauma, cancer, rheumatic diseases, coronary artery disease or stroke\n11. Patients participating in other investigational drug trials within one month of completion will be also excluded\n12. Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months\n13. Patients treated with statins or aspirin within past four weeks"}, 'identificationModule': {'nctId': 'NCT00819403', 'briefTitle': 'Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'HP-00040970'}, 'secondaryIdInfos': [{'id': 'MSP-JV IISP #32031'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'simvastatin', 'description': 'Simvastatin 40 mg daily', 'interventionNames': ['Drug: simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'simvastatin/ezetimibe', 'description': 'Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.', 'interventionNames': ['Drug: ezetimibe/simvastatin']}], 'interventions': [{'name': 'simvastatin', 'type': 'DRUG', 'otherNames': ['zocor'], 'description': 'Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.', 'armGroupLabels': ['simvastatin']}, {'name': 'ezetimibe/simvastatin', 'type': 'DRUG', 'otherNames': ['vytorin'], 'description': 'Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.', 'armGroupLabels': ['simvastatin/ezetimibe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'VA Maryland Health Care System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'MICHAEL MILLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, College Park'}, {'name': 'VICTOR L. Serebruany, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'President, HeartDrug Research LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Michael Miller', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}