Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT01587235
Status:
WITHDRAWN
Last Update Posted:
2022-02-18
First Post:
2012-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}], 'ancestors': [{'id': 'D019821', 'term': 'Simvastatin'}, {'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': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who Achieve Low-density Lipoprotein Cholesterol (LDL-C) goal (High-risk <100 mg/dL; Moderate-high and High risk <130 mg/dL)', 'timeFrame': 'Week 6'}], 'secondaryOutcomes': [{'measure': 'Change in LDL-C level From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL', 'timeFrame': 'Week 6'}, {'measure': 'Change in Serum LDL From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Change in Total Cholesterol From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Change in High-density lipoprotein (HDL) From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Change in Serum Triglycerides (TG) From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Change in Serum Non-HDL From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Change in LDL-C/HDL-C Ratio From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Change in Apolipoprotein B (ApoB) From Baseline', 'timeFrame': 'Baseline and Week 6'}, {'measure': 'Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL))', 'timeFrame': 'Week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL\n* Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment\n\nExclusion Criteria:\n\n* LDL-C level ≥ 190 mg/dL\n* Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin\n* Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)\n* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study\n* Currently participating in or has previously participated in a study within 30 days\n* Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months\n* Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes\n* Unstable angina pectoris\n* Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months\n* Unstable or severe peripheral artery disease within previous 3 months\n* Uncontrolled hypertension (treated or untreated)\n* Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)\n* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins\n* Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months\n* Received treatment with systemic corticosteroids, any cyclical hormones\n\nwithin previous 8 weeks'}, 'identificationModule': {'nctId': 'NCT01587235', 'acronym': 'VYCTORY', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Open-label, 6 Week Study to Evaluate the Efficacy and Safety of Algorithm Based Intensive Treatment With Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Patients.', 'orgStudyIdInfo': {'id': '0653A-406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vytorin', 'interventionNames': ['Drug: Ezetimibe/simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Other Statin', 'interventionNames': ['Drug: Other Statin']}], 'interventions': [{'name': 'Ezetimibe/simvastatin', 'type': 'DRUG', 'otherNames': ['Vytorin'], 'description': 'Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.', 'armGroupLabels': ['Vytorin']}, {'name': 'Other Statin', 'type': 'DRUG', 'description': 'Participants are prescribed a statin (any other than Vytorin) as per routine standard of care', 'armGroupLabels': ['Other Statin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}