NL-OMON40969已完成3 期
A 12-Week, Randomized, Double-Blind, Olive Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of EPANOVA* in Subjects With Severe Hypertriglyceridemia - EVOLVE II
Omthera Pharmaceuticals0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Qualifying (average of Visit 1 or 1a + Visit 2 + Visit 2a [repeat measurement]) serum
- •TG *500 mg/dL (5.65 mMol/L) and <2500 mg/dL (28.25 mMol/L);
- •2. Body mass index *20 kg/m2;
- •3. Untreated dyslipidemia or dyslipidemia treated with a statin, CAI, or statin-CAI
- •combination that has been stable for 6 weeks prior to randomization; and
- •4. Willingness to maintain current physical activity level and follow the TLC diet
- •throughout the study.
排除标准
- •1. Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish;
- •2. Known lipoprotein lipase impairment;
- •3. Known non-responder to omega-3 or fenofibrate therapy;
- •4. Use of any prescription medications containing EPA and/or DHA (eg, Lovaza® or
- •Vascepa®) within 8 weeks prior to randomization. Up to 1 g capsule/day of an omega-3
- •dietary supplement will be permitted;
- •5. Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other thanniacin-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 Visit 1;
- •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 in the 4 weeks prior to
- •8. History of hospitalization for pancreatitis in the last 5 years;
- •9. Uncontrolled diabetes (hemoglobin A1c >10%);
- •10. Uncontrolled hypothyroidism or thyroid-stimulating hormone >5 mIU/L;
- •11. History of cancer (other than basal cell carcinoma) in the past 2 years;
- •12. Cardiovascular event (ie, myocardial infarction, acute coronary syndrome, new onset
- •angina, stroke, transient heart attack, unstable congestive heart failure requiring a
- •change in treatment), revascularization procedure or vascular surgery within 6 months
- •of randomization;
- •13. Use of simvastatin 80 mg or Vytorin 10/80 mg;
- •14. Recent history (within 6 months of randomization) of significant nephrotic syndrome,
- •pulmonary, hepatic, biliary, gastrointestinal, or immunologic disease;
- •15. Poorly controlled hypertension (systolic blood pressure *180 mmHg and/or diastolic
- •blood pressure *110 mmHg) at two consecutive visits prior to randomization at Visit 3;
- •16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper
- •limit of normal;
- •17. Exposure to any investigational product within 4 weeks of Visit 1; or
- •18. Any condition or therapy which, in the opinion of the Investigator, might pose a risk to
- •the subject or make participation in the study not in the subject*s best interest.
研究者
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