Status:
COMPLETED
Study to Evaluate the Effect of Simvastatin, Losartan and Pioglitazone on Patients With Peripheral Arterial Disease.
Lead Sponsor:
Medtronic Endovascular
Collaborating Sponsors:
FoxHollow Technologies
Merck Sharp & Dohme LLC
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief 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 peri...
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 arter...
Eligibility Criteria
Inclusion
- Men and women =90 years of age.
- Bilateral lower extremity PAD requiring revascularization. Both extremities must have at least 1denovo atherosclerotic lesion
- Able to space bilateral atherectomy procedures by at least 6 weeks.
- Willing to provide informed consent to participation in genetic studies.
- Simvastatin Substudy
- LDL-C \>100 mg/dL and \<250 mg/dL TG\<350 mg/dL
- Not currently receiving or having taken a statin (simvastatin, lovastatin, rosuvastatin, atorvastatin, or pravastatin) or a combination product containing a statin for the previous 3 months.
- Losartan Substudy
- Diagnosis of hypertension with systolic blood pressure \>120 mm Hg but \<160 mm Hg, and diastolic blood pressure \>80 mm Hg but \<100 mm Hg.
- Not currently receiving or having taken an ACEi or ARB.
- Pioglitazone Substudy
- Type II diabetes mellitus
- HbA1c \>5.5% and \< 8.5%
- Otherwise on a stable glucose lowering regimen where no changes are expected in oral regimen, or where no changes in insulin doses of more than 10 U are expected.
- Not currently receiving or having taken a thiazolidinedione (rosiglitazone or pioglitazone) or a combination product containing a thiazolidinedione or the previous 12 months.
Exclusion
- Patient is pregnant, breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up.
- current condition, therapy, lab abnormality, mental legal incapacitation that in the investigator's judgment might confound the results of the study.
- Patient is currently participating in or has participated in a study with an investigational compound within 30 days of Visit 1.
- Patient has donated and/or received blood (including phlebotomy of \>300 mL) within 2 months prior to study.
- Surgery or significant trauma within 2 months prior to Visit 1.
- Patient is a user of recreational or illicit drugs or has had a recent history \<1yr drug/alcohol abuse\>2 alcoholic drinks per day).
- Patient was \<80% compliant with dosing during the placebo run-in period AND, in the opinion of the investigator, believed to be unable to maintain at least an 80% compliance with dosing during the active study dosing period.
- Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other coronary, carotid, or cerebral revascularization procedure,unstable angina, or angioplasty within 1 month of Visit 1. - Patient has chronic heart failure defined by New York Heart Association NYHA) Classes III or IV.
- Known clinically significant AV conduction disturbances or arrhythmias
- Patient has unstable hypertension (e.g., sitting systolic blood pressure \>160 mm Hg or diastolic \>100 mm Hg) at Visit 1.
- Any known clinically important bleeding or platelet disorder.
- Patient has history of ileal bypass, gastric bypass, other significant condition associated with malabsorption.
- Patient is HIV or hepatitis B positive.
- Patients with significantly elevated TSH at Visit 1 may be entered after consultation with and approval by the SPONSOR. Patients with a history of hypothyroidism, who are on a stable dose of thyroxine with normal TSH level at Visit 1 may be included.
- Patients on cyclical estrogen medications (Estrogen Replacement Therapy ERT\] or oral contraceptives). Patients on non-cyclical estrogen replacement therapy or Selective Estrogen Receptor Modulator (SERM) may be included, but must be on a stable dose for at least 8 weeks prior.
- Patients with active neoplastic disease which compromises their general health, or who currently require chemotherapy or radiation therapy, or who have completed chemotherapy or radiation therapy within 3 months prior.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00720577
Start Date
December 1 2005
End Date
August 1 2007
Last Update
May 14 2021
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