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Study to Evaluate the Effect of Simvastatin, Losartan and Pioglitazone on Patients With Peripheral Arterial Disease. — LEAP  

Peripheral Arterial Disease Clinical Trial

Official title:
Two-Part,Multicenter,Randomized,Double-Blind,Placebo-Controlled,Study to Evaluate the Effect of Simvastatin,Losartan,and Pioglitazone on Cardiovascular Disease Biomarkers in Lower Extremity Atherosclerotic Plaque Excised From Patients w/PAD

Clinical Trial Summary

Part A. The purpose of this study is to assess the effects of 6 weeks of treatment with, simvastatin, losartan or pioglitazone compared to placebo on the RNA expression profile of lower extremity peripheral arterial atherosclerotic plaque. Part B. The effect of simvastatin, losartan or pioglitazone compared to placebo on protein and lipid biomarkers in lower extremity peripheral arterial atherosclerotic plaque.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled, 6 week study. The study consists of 3 separate sub-studies in which patients undergoing bilateral lower extremity peripheral artery atherectomy will receive one of three FDA approved drugs known to have beneficial effect on the risk of cardiovascular disease. Patients will be selected for the particular sub-study based on a series of entry criteria and then randomized to the particular agent or placebo for 6-weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00720577
Study type Interventional
Source Medtronic Endovascular
Contact
Status Completed
Phase Early Phase 1
Start date December 2005
Completion date August 2007
View Details
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