Effects of Atorvastatin Versus Probucol on Small Dense LDL

• Sponsor: Yokohama City University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00276133
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Nephropathy	Drug: Effects of atorvastatin versus probucol on small dense LDL	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy
• Study Start Date: Jan 1, 2004
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Normalization of serum cholesterol concentrations [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yokohama City University Center Hospital	Yokohama	Kanagawa	Japan	232-0024

Sponsors and Collaborators

• Yokohama City University Medical Center

Investigators

• Principal Investigator: Gen Yasuda, MD, Yokohama City University Center Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00276133
• Other Study ID Numbers: 7332-1
• First Posted: Jan 12, 2006
• Last Update Posted: May 9, 2007
• Last Verified: May 1, 2007

• Keywords provided by , ,: small dense LDL
• Additional relevant MeSH terms: Kidney Diseases; Atorvastatin; Probucol

Study Results

No Results Posted as of May 9, 2007