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:
Yokohama City University Medical Center
Organization:
Study Overview
Official Title:
Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: