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Peripheral Arterial DiseaseEarly Phase 1LEAPNCT00720577

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

A Early Phase 1 study testing Simvastatin, Losartan and Pioglitazone in people with Peripheral Arterial Disease, run by Medtronic Endovascular.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Simvastatin, Losartan and Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
No sites listed yet
Study dates
Dec 2005to Aug 2007
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

About this 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

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.

Read the 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.

Keywords
Peripheral Arterial Disease, PAD, Lower extremity peripheral arterial atherosclerotic plaque, RNA Expression, Lipid Biomarkers
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimvastatinDrug

    Also called HMG-CoA reductase

    40 Mg. tablet, 1 tablet daily

  • LosartanDrug

    Also called Cozaar

    50 mg., tablets, 1 tablet once daily

  • PioglitazoneDrug

    Also called Systematic (IUPAC)

    30 mg, tablet, 1 tablet once daily

Study groups in NCT00720577
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Simvastatin
2Active comparatorNot described
Receives: Drug: Losartan
3Active comparatorNot described
Receives: Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate RNA expression profiles, protein and lipid biomarkers, and gene expression profiling on pts receiving simvastatin, losartan or pioglitazone.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Evaluate plaque characteristics in 3 patient subsets and Left and Right extremity comparisons.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2008 (estimated)
  2. Study startDec 2005
  3. Primary completionJul 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720577
Sponsor's protocol ID
FHT-P-05-005
Acronym
LEAP
Status last verified
Jul 2008
First submitted
21 Jul 2008
Last updated
14 May 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Simvastatin, Losartan and Pioglitazone in people with Peripheral Arterial Disease, run by Medtronic Endovascular.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate RNA expression profiles, protein and lipid biomarkers, and gene expression profiling on pts receiving simvastatin, losartan or pioglitazone. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00720577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.

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