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Sponsors and Collaborators: |
ev3 Endovascular, Inc. FoxHollow Technologies Merck |
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Information provided by: | ev3 Endovascular, Inc. |
ClinicalTrials.gov Identifier: | NCT00720577 |
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.
Condition | Intervention | Phase |
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Peripheral Arterial Disease |
Drug: Simvastatin Drug: Losartan Drug: Pioglitazone |
Phase 0 |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacodynamics Study |
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 |
Enrollment: | 164 |
Study Start Date: | December 2005 |
Study Completion Date: | August 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Simvastatin
40 Mg. tablet, 1 tablet daily
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2: Active Comparator |
Drug: Losartan
50 mg., tablets, 1 tablet once daily
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3: Active Comparator |
Drug: Pioglitazone
30 mg, tablet, 1 tablet once daily
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | FoxHollow Technologies ( Ev3) ( Neil Hattangadi M.D. , Vice President, Molecular Programs ) |
Study ID Numbers: | FHT-P-05-005 |
Study First Received: | July 21, 2008 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00720577 |
Health Authority: | United States: Institutional Review Board |
Peripheral Arterial Disease PAD Lower extremity peripheral arterial atherosclerotic plaque RNA Expression Lipid Biomarkers |
Losartan Peripheral Vascular Diseases Pioglitazone |
Simvastatin Vascular Diseases Angiotensin II |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents Antihypertensive Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Hypoglycemic Agents Therapeutic Uses Cardiovascular Diseases Anti-Arrhythmia Agents |