NCT00720577

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Simvastatin	40 Mg. tablet, 1 tablet daily
DRUG	Losartan	50 mg., tablets, 1 tablet once daily
DRUG	Pioglitazone	30 mg, tablet, 1 tablet once daily

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-07-01
• Completion: 2007-08-01
• First posted: 2008-07-23
• Last updated: 2021-05-14