Status:
UNKNOWN
Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy
Lead Sponsor:
Azienda Ospedaliero Universitaria di Sassari
Conditions:
Hypercholesterolemia
Chronic Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 achi...
Detailed Description
Patients with chronic kidney disease (CKD) have an increased incidence of cardiovascular morbidity and mortality. Presence of hypertension, lipid abnormalities and inflammation each contribute to incr...
Eligibility Criteria
Inclusion
- age \>18 years
- LDL-cholesterol \> 100 mg/dl (without concomitant hypolipidemic drugs) in patients whit high cardiovarscular risk for the concomitant presence of:
- proteinuric chronic nephropathy defined as creatinine clearance \> 20 ml/min/1,73 m2 combined to a urinary protein excretion rate \> 0,3 g/24h, without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
- hypertension defined as a systolic or diastolic blood pressure \> 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)
Exclusion
- previous or concomitant treatment with steroids, anti-inflammatory and immunosuppressive agents
- evidence or suspicion of renovascular disease, obstructive uropathy, type I diabetes mellitus, vasculitides, history of poor tolerance or allergy to ACEi and ATA, statin or EZE, drug abuse or pregnancy
- inability to fully understand the purposes/risks of the study and to provide a written informed consent
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00861731
Start Date
November 1 2008
End Date
July 1 2009
Last Update
April 28 2009
Active Locations (1)
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1
Istituto di Patologia Medica - Azienda Ospedaliero Universitaria
Sassari, Italy, 07100