NCT02009865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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Percent Change in Triglyceride for All Subjects
研究概览
简要总结
This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia. The study consists of an approximately 8-week screening period that includes a diet and lifestyle stabilization and washout period and a 12-week treatment period.
详细描述
[During the screening period and treatment period, all visits are to be within ±3 days of the scheduled time.]
Screening Period:
Visit 1 will occur at Week -8 for subjects requiring washout and/or statin, cholesterol-absorption inhibitor (CAI), or statin-CAI stabilization. This includes subjects who:
- Were previously on omega-3 drugs/supplements;
- Require adjustment to or addition of permitted statins, CAI, or statin-CAI combination;
- Have not been on a permitted stable dose of statin, CAI, or statin-CAI combination for at least 4 weeks prior to Visit 1; and/or
- Need to washout of bile acid sequestrants, fibrates, niacin, and other supplements known to alter lipid metabolism.
For these subjects who require washout and/or statin, CAI, or statin-CAI stabilization, at Visit 1 (Week -8) screening procedures will be performed. Subjects will return at Visit 1a (Week -2) for their first qualifying lipid measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understanding of the study procedures, willingness to adhere to the study schedule, and agreement to participate in the study by giving written informed consent prior to screening;
- •Willing to use an appropriate and effective method of contraception;
- •Qualifying (average of Visit 1 or 1a + Visit 2 + Visit 2a [repeat measurement]) serum TG ≥500 mg/dL (6 mMol/L) and <2500 mg/dL (28 mMol/L);
- •Body mass index ≥20 kg/m2;
- •Untreated dyslipidemia or dyslipidemia treated with a statin, CAI, or statin-CAI combination that has been stable for 6 weeks prior to randomization; and
- •Willingness to maintain current physical activity level and follow the TLC diet throughout the study.
排除标准
- •Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish;
- •Known lipoprotein lipase impairment;
- •Known non-responder to omega-3 or fenofibrate therapy;
- •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;
- •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 screening;
- •Use of tamoxifen, estrogens, or progestins that has not been stable for >4 weeks at screening or is unstable prior to randomization;
- •Use of oral or injected corticosteroids or anabolic steroids prior to randomization;
- •History of hospitalization for pancreatitis in the last 5 years;
- •Uncontrolled diabetes (hemoglobin A1c [HbA1c] >10%);
- •Uncontrolled hypothyroidism or thyroid-stimulating hormone (TSH) >5 mIU/L;
- •History of cancer (other than basal cell carcinoma) in the past 2 years;
- •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;
- •Use of simvastatin 80 mg or Vytorin 10/80 mg;
- •Recent history (within 6 months of randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal, or immunologic disease;
- •Poorly controlled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN); if ALT/AST is >3 × ULN, the levels have been stable for 3 months and are <5 × ULN;
- •Exposure to any investigational product within 4 weeks of randomization; or
- •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.
研究组 & 干预措施
Olive Oil 2 g/day
Placebo Comparator
Arm 2
干预措施: Olive Oil (Drug)
Epanova 2 g/day
Experimental
Arm 1
干预措施: Epanova (Drug)
结局指标
主要结局
Percent Change in Triglyceride for All Subjects
时间窗: From Baseline to Week 12 Endpoint
This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.
次要结局
- Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL)(From Baseline to Week 12 Endpoint)
- Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL(From Baseline to Week 12 Endpoint)
- Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6)(From Baseline to Week 12 Endpoint)
- Percent Change in High-Density Lipoprotein Cholesterol (mg/dL)(From Baseline to Week 12 Endpoint)
研究者
研究点 (1)
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