NCT04221217已完成3 期
Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia
Mochida Pharmaceutical Company, Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年2月14日最近更新:
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
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.
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
- None
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 (DAPT).
- •Participants taking direct oral anticoagulants (DOAC) or warfarin.
研究组 & 干预措施
MND-2119 2g
Experimental
MND-2119 2 g, orally, once daily after breakfast for 52 weeks.
干预措施: Icosapent (Drug)
MND-2119 4g
Experimental
MND-2119 4 g, orally, once daily after breakfast for 52 weeks.
干预措施: Icosapent (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: 52 Weeks
次要结局
- Actual Value and Percent Change From Baseline in Triglyceride(Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)(Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Number of Participants With Adverse Drug Reactions (ADRs)(52 Weeks)
- Actual Value and Percent Change From Baseline in Total Cholesterol(Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)(Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)(Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
研究者
研究点 (1)
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