Efficacy of MND-2119 in Participants With Hypertriglyceridemia
赞助:
Mochida Pharmaceutical Company, Ltd.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 30, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration[ Time Frame: Baseline and 12 weeks ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Efficacy of MND-2119 in Participants With Hypertriglyceridemia | ||
| 正式标题 ICMJE | MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia | ||
| 简要概况 | The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia. |
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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 3 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
580 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 2019 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Participants diagnosed with hypertriglyceridemia. 2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL. Exclusion Criteria: 1. Participants who have confirmed myocardial infarction and angina pectoris within 6 months. 2. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months. 3. Participants with, or with a history of, pancreatitis. 4. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months. 5. Participants taking both anti-coagulants and anti-platelets. 6. Participants receiving dual antiplatelet therapy. 7. Participants taking direct oral anticoagulants. | ||
| 性别 |
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| 年龄 | 最小年龄：20 Years ，最大年龄：74 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Japan | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Mochida Pharmaceutical Company, Ltd. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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