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| Sponsored by: |
Yokohama City University Medical Center |
|---|---|
| Information provided by: | Yokohama City University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00276133 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy |
| Enrollment: | 24 |
| Study Start Date: | January 2004 |
| Study Completion Date: | May 2007 |
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| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan, Kanagawa | |
| Yokohama City University Center Hospital | |
| Yokohama, Kanagawa, Japan, 232-0024 | |
| Principal Investigator: | Gen Yasuda, MD | Yokohama City University Center Hospital |
| Principal Investigator: | Gen Yasuda, MD | Yokohama City University Center Hospital |
More Information
| Study ID Numbers: | 7332-1 |
| Study First Received: | January 11, 2006 |
| Last Updated: | May 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00276133 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
small dense LDL |
|
Antimetabolites Antioxidants Probucol Urologic Diseases Antilipemic Agents |
Anticholesteremic Agents Kidney Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Atorvastatin |
|
Antimetabolites Probucol Antioxidants Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Protective Agents Pharmacologic Actions Urologic Diseases Therapeutic Uses Kidney Diseases Atorvastatin |
