Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-19 @ 11:56 AM
Study NCT ID:
NCT00566267
Status:
COMPLETED
Last Update Posted:
2007-12-03
First Post:
2007-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], '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': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-30', 'studyFirstSubmitDate': '2007-11-29', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL cholesterol', 'timeFrame': '8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Other lipid measures', 'timeFrame': '8 weeks of treatment'}, {'measure': 'Safety and tolerability', 'timeFrame': '8 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '20435205', 'type': 'DERIVED', 'citation': 'Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: a randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6. doi: 10.1016/j.ahj.2010.02.010.'}]}, 'descriptionModule': {'briefSummary': 'People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderately obese with hyperlipidemia\n\nExclusion Criteria:\n\n* Recent unstable heart or lung condition\n* Current use of other lipid modifying drugs\n* Hepatic disease\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00566267', 'acronym': 'LOCUST', 'briefTitle': 'A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet', 'organization': {'class': 'FED', 'fullName': 'Corporal Michael J. Crescenz VA Medical Center'}, 'officialTitle': 'A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet', 'orgStudyIdInfo': {'id': '00887'}, 'secondaryIdInfos': [{'id': 'MIRB Number: 00887'}, {'id': 'PROM # 0025'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg', 'interventionNames': ['Drug: simvastatin 20 mg/ezetimibe']}], 'interventions': [{'name': 'simvastatin 20 mg/ezetimibe', 'type': 'DRUG', 'otherNames': ['Low carb diet plus simvastatin 20 mg'], 'description': 'see protocol', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frederick F Samaha, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philadelphia VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Frederick F. Samaha, M.D.'}}}}