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Effects of Atorvastatin Versus Probucol on Small Dense LDL

NCT ID: NCT00276133

Last Updated: 2007-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Effects of atorvastatin versus probucol on small dense LDL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yokohama City University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Gen Yasuda, MD

Role: PRINCIPAL_INVESTIGATOR

Yokohama City University Center Hospital

Locations

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Yokohama City University Center Hospital

Yokohama, Kanagawa, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 15462110 (View on PubMed)

Other Identifiers

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7332-1

Identifier Type: -

Identifier Source: org_study_id