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Effects of Atorvastatin Versus Probucol on Small Dense LDL

Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00276133
Enrollment
24
Registered
2006-01-12
Start date
2004-01-31
Completion date
2007-05-31
Last updated
2007-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Nephropathy

Keywords

small dense LDL

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.

Interventions

DRUGEffects of atorvastatin versus probucol on small dense LDL

Sponsors

Yokohama City University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Normalization of serum cholesterol concentrationsOne year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026