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Effects of Atorvastatin Versus Probucol on Small Dense LDL

Primary Purpose

Chronic Nephropathy

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Effects of atorvastatin versus probucol on small dense LDL
Sponsored by
Yokohama City University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nephropathy focused on measuring small dense LDL

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yokohama City University Center Hospital

Outcomes

Primary Outcome Measures

Normalization of serum cholesterol concentrations

Secondary Outcome Measures

Full Information

First Posted
January 11, 2006
Last Updated
May 8, 2007
Sponsor
Yokohama City University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00276133
Brief Title
Effects of Atorvastatin Versus Probucol on Small Dense LDL
Official Title
Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yokohama City University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nephropathy
Keywords
small dense LDL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Effects of atorvastatin versus probucol on small dense LDL
Primary Outcome Measure Information:
Title
Normalization of serum cholesterol concentrations
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gen Yasuda, MD
Organizational Affiliation
Yokohama City University Center Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yokohama City University Center Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15462110
Citation
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. doi: 10.1081/jdi-120039826.
Results Reference
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Effects of Atorvastatin Versus Probucol on Small Dense LDL

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