Effects of Atorvastatin Versus Probucol on Small Dense LDL

Phase 4

Completed

• Conditions: Chronic Nephropathy

• Registration Number: NCT00276133
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Status Verified: 2007-05
• Study Completion: 2007-05
• Last Update Submitted: 2007-05-08
• Last Update Posted: 2007-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Hyperlipidemic patients with non-diabetic nephropathy

Exclusion Criteria

• Endocrinological, hematological or hepatic disease
• Cerebral infarction or hemorrhage
• Homozygous familial hypercholesterolemia
• Uncontrolled hypertension
• Myocardial infarction occurring within the previous 6 months
• Unstable angina
• Diabetic nephropathy
• Abnormal thyroid function
• Receiving steroids or immunosuppressive agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Normalization of serum cholesterol concentrations	One year

Trial Locations

Locations (1)

Yokohama City University Center Hospital; 🇯🇵 Yokohama, Kanagawa, Japan