A 6-Week, Randomized, Double-Blind, Placebo(Olive Oil)-Controlled Study to Assess the Efficacy and Safety of Add-On Epanova® to Statin Therapy in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 646
- 主要终点
- Serum Non-HDL Cholesterol
研究概览
简要总结
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.
详细描述
The primary efficacy variable is serum non-HDL cholesterol. The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups. Baseline is defined as the average of Visits 2, 3 and 4 (Weeks -2, -1 and 0) and end-of-treatment is the average of Visits 5 and 6 (Weeks 5 and 6).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, ≥18 years of age.
- •Fasting triglyceride (TG) level ≥200 mg/dL and <500 mg/dL.
- •The subject is a high risk for a future cardiovascular event.
- •The subject is treated with a statin and at or near LDL-C goal.
排除标准
- •Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.
- •Use of fibrates, bile acid sequestrants, or niacin or its analogues (greater than 200 mg/d) during screening.
- •Use of simvastatin 80 mg or Vytorin10/80 mg during screening.
- •Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products.
- •Use of any supplement for the purpose of lowering plasma cholesterol during screening.
- •Use of weight loss drugs or programs during screening.
- •Use of erythromycin, telithromycin, clarithromycin, cyclosporine, itraconazole, ketoconazole, protease inhibitors, or nefazodone during screening.
- •Use of anticoagulants during screening.
- •Use of oral or injected corticosteroids during screening.
- •Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4 weeks at Visit 1, or is unstable during screening.
- •Use of >750 mL/d grapefruit juice during screening.
- •Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
- •History of pancreatitis.
- •Type I diabetes mellitus, use of insulin, or HbA1c >10% at Visit
- •Poorly controlled hypertension
- •Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >1.5xULN at Visit
- •Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
- •History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.
- •Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception.
- •Creatine kinase >5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN at Visit
- •Current or recent history (past 12 months) of drug or alcohol abuse.
- •Exposure to any investigational agent within 4 weeks prior to Visit
- •Any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
研究组 & 干预措施
Olive Oil
olive oil: 4 g/day + prescription statin
干预措施: Olive oil, 4g (Drug)
Epanova, 2 g
omega-3-carboxylic acids, 2g/day + prescription statin
干预措施: omega-3-carboxylic acids, 2g (Drug)
Epanova, 4 g
omega-3-carboxylic acids, 4g/day + prescription statin
干预措施: omega-3-carboxylic acids, 4g (Drug)
结局指标
主要结局
Serum Non-HDL Cholesterol
时间窗: 6 weeks
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.
次要结局
未报告次要终点