NCT02625870Unknown3 期
A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hypertriglyceridemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 主要终点
- End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
研究概览
简要总结
The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but <2000 mg/dL).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.At least 2 times of fasting serum TG concentrations≥500 mg/dL but<2000 mg/dL at screening (2and 1 and 0 weeks before random assignment).
- •2.Two times qualified High Triglycerides Dietary Assessment Table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in Chinese adults Guide ".
排除标准
- •1.Unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study.
- •2.Patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase.
- •3.Subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study.
- •4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 times the upper limit of normal.
- •5.Serum creatinine >176μmol/L. 6.Platelet counts<60×109/L，hemoglobin <100 g/L. 7.Poorly controlled hypertension(resting blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic) 8.Uncontrolled type II diabetes(fasting blood sugar >11.1mmol/L). 9.Type II diabetes, nephrotic syndrome, hypothyroidism. 10.Atrial fibrillation. 11.History of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy.
- •12.History of cancer (other than basal cell carcinoma) in the past 2 years. 13.Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
- •14.History in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary.
- •15.Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.
研究组 & 干预措施
Omega-3-Acid Ethyl Esters 90 Soft Capsules
Experimental
干预措施: Omega-3-Acid Ethyl Esters 90 Soft Capsules (Drug)
Corn Oil
Placebo Comparator
干预措施: Corn Oil (Drug)
结局指标
主要结局
End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
时间窗: 12 weeks
次要结局
- End-of-treatment Apo C3 percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment non-HDL-C percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment TC percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment VLDL-C percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment HDL-C percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment LDL-C percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions(12 weeks)
- End-of-treatment Apo A5 percentage change from baseline under fasting conditions(12 weeks)
研究者
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