Efficacy and Safety of Epanova® in Severe Hypertriglyceridemia - EVOLVE/OM-EPA-003

Omthera Pharmaceuticals, Inc0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1.Men or women, *18 years of age.
•2.Serum TG values in the range *500 mg/dL and <2000 mg/dL (*5.65 mmol/L and <22.60 mmol/L) for the average of Visits 2 and 3 (Weeks -2 and -1). Repeat of Visit 3 test is allowed (Visit 3a), and the average of Visit 2 (Week -2) + Visit 3 (Week -1) + Visit 3a (repeat visit) is used as the criterion.
•3.Body mass index *20 kg/m2.
•4.Untreated dyslipidemia, or use of a statin or cholesterol absorption inhibitor, or their combination, if stable for 6 weeks at Visit 2 (Week -2) and prior to randomization.
•5.Willing to restrict consumption of fish to no more than twice per week during the study.
•6.Willingness to maintain current activity level and follow TLC diet.

•1.Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
•2.Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
•3.Unable to discontinue use of omega-3 drugs/supplements at Week -8 (Visit 1).
•4.Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins <200 mg), or any supplement used to alter lipid metabolism, including
•but not limited to: dietary fiber supplements, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols at Week -4 (Visit 1).
•5.Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Examples of acceptable contraceptive methods include abstinence, intrauterine device (IUD) or double barrier method. Estrogen-containing contraceptives are excluded.
•6.Use of tamoxifen, estrogens or progestins that has not been stable for >4 weeks at Visit 1, or is unstable prior to randomization.
•7.Use of oral or injected corticosteroids or anabolic steroids at Visit 1 or prior to randomization.
•8.History of pancreatitis.
•9.History of symptomatic gallstone disease, unless treated with cholecystectomy.

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