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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT01025492
Eligibility Criteria:
Inclusion Criteria:
* Triglyceride 150-500 mg/dL
* HDL-C \< 45 mg/dL in men, \< 55 in women
* LDL-C \< 130 mg/dL
* stable statin dose x 8 weeks
Exclusion Criteria:
* Prior use of a fibrate \> 4 weeks ever (minimum 12 months off fibrate)
* Intolerance to medications to be used in study (fenofibric acid, albuterol, nitroglycerin)
* Niacin or thiazolidinedione within the prior 12 months, or anticipated need to add either during 6-month study period
* Diabetes Mellitus if either (1) diagnosed less than 3 months ago, (2) treated with insulin, or (3) with an A1c \>8%
* Anticipated need to change treatment regimen of statin (or other lipid agent) or glycemic treatment during 6-month study period
* Uncontrolled hypertension (BP \> 140/90 mm Hg), or changes in BP meds within prior 4 weeks, or anticipated need to change BP meds during 6-month study period
* Documented cardiovascular disease event (heart attack, stroke, or hospitalization for unstable angina or revascularization procedure) in the past 6 months
* Use of warfarin (potential to interact adversely with fibrate therapy)
* Uncontrolled thyroid disease (TSH outside of normal range)
* Renal insufficiency (calculated Glomerular Filtration Rate \<50 ml/min)
* Hepatic disease (ALT \> 1.5x Upper Limit of Normal, diagnosis of hepatitis, cirrhosis)
* Active cholecystitis/cholelithiasis
* Active cancer (except basal cell or squamous cell skin cancer)
* Pregnancy, plan/desire to become pregnant, breast feeding
* Inability or unwillingness to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT01025492
Study Brief:
Protocol Section:
NCT01025492