JPRN-jRCT2080222896已完成3 期
A Long-Term Outcomes Study to Assess Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 305
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patient must be on a stable diet and statin therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
- •a. LDL-C <100 mg/dL
- •b. TG level 180 or more and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
- •- Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c) is present via patient history, physical exam, or medical records at the time of screening:
- •a. Any atherosclerotic CVD as defined in protocol.
- •b. History of diabetes mellitus (type 1 or 2) and 40 years of age or more for men and 50 years of age or omore for women, plus one of
- •the risk factors defined in protocol.
- •c. Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.
排除标准
- •- Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil.
- •- Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2.
- •- Statin naive at Visit 1.
研究者
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