Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy
NCT00861731 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2009-04-28
Summary
The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).
Conditions
- Hypercholesterolemia
- Chronic Nephropathy
Interventions
- DRUG
-
simvastatin
simvasatin therapy alone at the dose of 40 mg/day
- DRUG
-
EZE/simvastatin
EZE/simvastatin combined therapy at the dose of 10/20 mg/day
- DRUG
-
EZE/simvastatin
EZE/simvastatin combined therapy at the dose of 10/40 mg/day
Sponsors & Collaborators
-
Azienda Ospedaliero Universitaria di Sassari
lead OTHER
Principal Investigators
-
Andrea E Satta, MD · Istituto di Patologia Medica -Azienda Ospedaliero Universitaria di Sassari
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2009-07-31
- Completion
- 2009-07-31
Countries
- Italy
Study Locations
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