Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy

NCT00861731 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-04-28

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861731 on ClinicalTrials.gov