MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
详细描述
MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia.
The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks treatment period and 2 weeks follow-up period.
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with hypertriglyceridemia.
- •Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.
排除标准
- •Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
- •Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
- •Participants with, or with a history of, pancreatitis.
- •Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
- •Participants taking both anti-coagulants and anti-platelets.
- •Participants receiving dual antiplatelet therapy.
- •Participants taking direct oral anticoagulants.
研究组 & 干预措施
MND-2119 2 g
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
干预措施: Icosapent (MND-2119) (Drug)
MND-2119 4 g
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
干预措施: Icosapent (MND-2119) (Drug)
EPADEL CAPSULES 300 1.8 g
EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
干预措施: Icosapent (EPADEL CAPSULES 300) (Drug)
EPADEL CAPSULES 300 2.7 g
EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.
干预措施: Icosapent (EPADEL CAPSULES 300) (Drug)
结局指标
主要结局
Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
时间窗: Baseline and 12 weeks
次要结局
- Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
- Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) (direct method) level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
- Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
- Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
- Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)