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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT00071266
Eligibility Criteria:
INCLUSION CRITERIA:
* Men \& women at least 40 years of age or older. Women must not be pregnant nor breast-feeding \& not planning to become pregnant or to breast-feed.
* History of IC of the lower extremities which has been present for at least 6 months with no change in symptoms in the previous 3 months prior to screening.
* LDL-C of \<160 mg/dL and Triglycerides \<800.
EXCLUSION CRITERIA:
* Severe neuropathy.
* Gross obesity (BMI ≥ 40).
* Presence of critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
* Surgical intervention to alleviate symptoms of claudication within 6 months or endovascular interventions within 3 months.
* Documented CAD taking any cholesterol-modifying agent and unable to undergo washout as judged by the Investigator or due to personal choice.
* Systolic blood pressure ≥160 mmHg \&/or diastolic blood pressure ≥95 mmHg.
* Presence of clinically significant laboratory test abnormalities for liver or renal function tests, thyroid function or HgbA1C.
* History of alcohol abuse or currently drinks alcohol in excess.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00071266
Study Brief:
Protocol Section:
NCT00071266