NCT04177680已完成2 期
Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acid to ENHANCE Efficacy in Adults With Hypertriglyceridemia: The ENHANCE-IT Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
研究概览
简要总结
Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
详细描述
An open-label, randomized, crossover study to assess the pharmacodynamic effects of MAT-9001, an omega-3 free fatty acid compared to Vascepa (icosapent ethyl) on triglycerides and other lipoprotein lipids in men and women with elevated triglycerides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female, ≥18 y of age
- •Judged to be in generally good health
- •Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening
- •Body mass index of ≥20.0 kg/m2
- •No clinically significant findings in a 12-lead ECG or physical examination
- •Willing and able to undergo the scheduled study procedures
- •Understands study procedures and signs forms documenting informed consent to participate in the study
排除标准
- •Laboratory test result of clinical significance
- •Uncontrolled hypertension
- •Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder
- •History of human immunodeficiency virus, hepatitis B or hepatitis C infection
- •Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit
- •Active systemic infection
- •A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol
研究组 & 干预措施
Omega-3 pentaenoic acid (MAT9001)
Experimental
2g MAT9001 capsules twice daily with meals
干预措施: Omega 3 pentaenoic acid (Drug)
Icosapent ethyl (Vascepa)
Active Comparator
2g Vascepa capsules twice daily with meals
干预措施: icosapent ethyl (Drug)
结局指标
主要结局
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
时间窗: baseline to 28 days
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
次要结局
- Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)(baseline to 28 days)
- Percent Change in Lipoprotein Lipids (Per Protocol Population)(baseline to 28 days)
- Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)(baseline to 28 days)
- Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)(Baseline to 28 days)
研究者
研究点 (2)
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