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Effects of Atorvastatin Versus Probucol on Small Dense LDL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276133
First Posted: January 12, 2006
Last Update Posted: May 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yokohama City University Medical Center
  Purpose
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 Intervention Phase
Chronic Nephropathy Drug: Effects of atorvastatin versus probucol on small dense LDL Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • Normalization of serum cholesterol concentrations [ Time Frame: One year ]

Enrollment: 24
Study Start Date: January 2004
Study Completion Date: May 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276133


Locations
Japan
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00276133     History of Changes
Other Study ID Numbers: 7332-1
First Submitted: January 11, 2006
First Posted: January 12, 2006
Last Update Posted: May 9, 2007
Last Verified: May 2007

Keywords provided by Yokohama City University Medical Center:
small dense LDL

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Atorvastatin Calcium
Probucol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antioxidants
Protective Agents
Physiological Effects of Drugs


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