Skip to main content
OpenTrials
Completed

NCT Number: NCT00276133

Effects of Atorvastatin Versus Probucol on Small Dense LDL

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yokohama City University Center Hospital

Yokohama, Kanagawa, 232-0024, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effects of atorvastatin versus probucol on small dense LDL

Drug

Primary outcomes

  1. Normalization of serum cholesterol concentrations

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Yokohama City University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Jan 12, 2006
Registry last updated
May 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.