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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01997268
Eligibility Criteria:
Inclusion Criteria:
* Be male or female, age 18 years
* Have a TG level ≥500 mg/dL and ≤2,000 mg
* Have the ability to understand the requirements of the study and be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions and return for the required assessments.
* Be normally active and in good health on the basis of medical history.
* Willing to maintain a stable diet and not alter their physical activity level throughout the study.
* Women of childbearing potential must be willing to use accepted birth control methods throughout the study.
Exclusion Criteria:
* Women who are pregnant, planning to become pregnant, or breastfeed during the study period
* History of pancreatitis
* Hemoglobin A1c \> 9.5% (subjects with diabetes mellitus will be required to receive stable therapy)
* History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary vascularization within 6 months before screening
* Thyroid-stimulating hormone \> 1.5 x upper limit of normal; clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for
* 6 weeks before screening
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal
* An unexplained creatine kinase concentration \> 3 x upper limit of normal or creatine kinase elevation due to known muscle disease (e.g., polymyositis, mitochondrial dysfunction)
* Blood donation of ≥1 pint within 30 days before screening or plasma donation within 7 days before screening
* The consumption of \>2 alcoholic beverages per day after screening; a history of illicit drug use within 1 year before screening
* A history of symptomatic gallstone disease unless treated with cholecystectomy
* Known nephrotic syndrome or \>3 g/day proteinuria
* Allergy or intolerance to omega-3 fatty acids, ethyl esters, or fish; known lipoprotein lipase impairment or deficiency or apoC-II deficiency or familial dysbetalipoproteinemia
* History of cancer (other than basal cell carcinoma of the skin) in the past 2 years; and a history or evidence of major and clinically significant disease that could adversely affect the conduct of the study or patient safety.
* Use acetylcholinesterase inhibitors or memantine, in the prior 2 months to screening
* Use of a lipase inhibitor such as Xenical (orlistat)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01997268
Study Brief:
Protocol Section:
NCT01997268