Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT00153166
Eligibility Criteria:
Inclusion Criteria:
* symptomatic intermittent claudication for \>= 6 months
* resting ankle/brachial index (ABI) \<=0.90
* maximal treadmill walking time between 1-20 minutes
* \>= 20% decrease in ABI post treadmill exercise
* 4 week statin wash-out prior to initial study testing (if applicable)
Exclusion Criteria:
* myocardial infarction or coronary artery bypass surgery within past 6 months
* lower extremity revascularization (surgical or percutaneous) within past 6 months
* transient ischemic attack or ischemic stroke within past 6 months
* pregnancy
* uncontrolled hypertension (systolic pressure \> 180mmHg and/or diastolic pressure \> 100mmHg
* serum creatinine \>2.5
* hepatic transaminases (AST, ALT) \> 3x upper limit of normal (ULN)
* creatine kinase \> 5x ULN
* known hypersensitivity to HMG-CoA reductase inhibitors
* insulin dependent Type 2 diabetes
* current treatment with thiazolidinedione
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT00153166
Study Brief:
Protocol Section:
NCT00153166