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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date05 Oct 1994 |
中国健康受试者口服Vascepa(ICOSAPENT ETHYL)胶囊的多剂量给药、随机、开放、平行设计的I期试验
[Translation] A multiple-dose, randomized, open-label, parallel-design phase I trial of oral Vascepa (ICOSAPENT ETHYL) capsules in healthy Chinese subjects
评价中国健康受试者连续28天口服Vascepa胶囊后血浆和红细胞EPA的药代动力学(PK)特征及连续28天口服Vascepa胶囊的安全性
[Translation] To evaluate the pharmacokinetic (PK) characteristics of plasma and red blood cell EPA after 28 consecutive days of oral administration of Vascepa capsules in healthy Chinese subjects and the safety of 28 consecutive days of oral administration of Vascepa capsules
一项评估空腹甘油三酯水平≥500 mg/dL且≤2000 mg/dL的受试者接受Vascepa治疗的疗效和安全性的III期研究
[Translation] A Phase III study evaluating the efficacy and safety of Vascepa in subjects with fasting triglyceride levels ≥500 mg/dL and ≤2000 mg/dL
本研究的主要目的是评估空腹TG水平≥500 mg/dL且≤2000 mg/dL(≥5.6 mmol/L且≤22.6 mmol/L)的受试者接受ICOSAPENT ETHYL (IPE)4 g/日治疗或2 g/日治疗与安慰剂相比在降低空腹TG水平方面的疗效。 本研究的次要目的如下: 1. 评估ICOSAPENT ETHYL (IPE)4 g/日治疗的安全性和耐受性; 2. 评估ICOSAPENT ETHYL (IPE)2 g/日治疗的安全性和耐受性; 3. 评估对极低密度脂蛋白胆固醇(VLDL-C)的影响; 4. 评估对载脂蛋白B(apo B)的影响;
[Translation] The primary objective of this study is to evaluate the efficacy of ICOSAPENT ETHYL (IPE) 4 g/day or 2 g/day compared with placebo in reducing fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤2000 mg/dL (≥5.6 mmol/L and ≤22.6 mmol/L). The secondary objectives of this study are as follows: 1. To evaluate the safety and tolerability of ICOSAPENT ETHYL (IPE) 4 g/day treatment; 2. To evaluate the safety and tolerability of ICOSAPENT ETHYL (IPE) 2 g/day treatment; 3. To evaluate the effect on very low-density lipoprotein cholesterol (VLDL-C); 4. To evaluate the effect on apolipoprotein B (apo B);
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