Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00276133
Status:
COMPLETED
Last Update Posted:
2007-05-09
First Post:
2006-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Atorvastatin Versus Probucol on Small Dense LDL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-08', 'studyFirstSubmitDate': '2006-01-11', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2007-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normalization of serum cholesterol concentrations', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['small dense LDL'], 'conditions': ['Chronic Nephropathy']}, 'referencesModule': {'references': [{'pmid': '15462110', 'type': 'BACKGROUND', 'citation': 'Yasuda G, Kuji T, Hasegawa K, Ogawa N, Shimura G, Ando D, Umemura S. Safety and efficacy of fluvastatin in hyperlipidemic patients with chronic renal disease. Ren Fail. 2004 Jul;26(4):411-8. doi: 10.1081/jdi-120039826.'}]}, 'descriptionModule': {'briefSummary': 'Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.', 'detailedDescription': 'The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day) and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3-2.0 g/day, and creatinine clearance \\> 30 ml/min/1.73 m2 or serum creatinine concentration \\< 2 mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary albumin to creatinine excretion ratio are measured before and during treatment periods. It will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and probucol significantly increase the LDL particle size, third, whether significant differences in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both groups during treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperlipidemic patients with non-diabetic nephropathy\n\nExclusion Criteria:\n\n* Endocrinological, hematological or hepatic disease\n* Cerebral infarction or hemorrhage\n* Homozygous familial hypercholesterolemia\n* Uncontrolled hypertension\n* Myocardial infarction occurring within the previous 6 months\n* Unstable angina\n* Diabetic nephropathy\n* Abnormal thyroid function\n* Receiving steroids or immunosuppressive agents'}, 'identificationModule': {'nctId': 'NCT00276133', 'briefTitle': 'Effects of Atorvastatin Versus Probucol on Small Dense LDL', 'organization': {'class': 'OTHER', 'fullName': 'Yokohama City University Medical Center'}, 'officialTitle': 'Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy', 'orgStudyIdInfo': {'id': '7332-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Effects of atorvastatin versus probucol on small dense LDL', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Center Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Gen Yasuda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yokohama City University Center Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yokohama City University Medical Center', 'class': 'OTHER'}}}}