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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT00083369
Eligibility Criteria:
Inclusion criteria:
1. ≥18 years of age
2. fasting TGs \<1,500 mg/dl
3. willingness to participate in the study and attend the scheduled clinic exams
4. member of a family with at least two members in a sibship
5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) results within normal range
6. creatinine ≤2.0 mg/dl
Exclusion criteria:
1. history of liver, kidney, pancreas, or gall bladder disease or malabsorption
2. current pregnancy
3. insulin use
4. use of lipid-lowering drugs (including prescription, over the counter, and nutriceuticals; volunteers taking these agents were withdrawn from them at least 4 weeks prior to the study with physician's approval)
5. use of warfarin
6. women of childbearing potential not using an acceptable form of contraception
7. known hyper-sensitivity to fenofibrate
8. history of pancreatitis within 12 months prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00083369
Study Brief:
Protocol Section:
NCT00083369