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

NCT00720577 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2021-05-14

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

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

Sponsors & Collaborators

  • FoxHollow Technologies

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-07-31
Completion
2007-08-31

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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 NCT00720577 on ClinicalTrials.gov