Randomized Head-to-Head Comparison of Coenzyme A Capsule and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia: A Phase III, Multicenter, Double-blinded, Double Dummy Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- serum triglyceride level
研究概览
简要总结
The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in Chinese patients with moderate dyslipidemia.
详细描述
Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule by comparing with fenofibrate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •TG 2.3～6.5mmol/l
- •18-75 years of age
排除标准
- •TC >7.0 mmol/l;
- •Body Mass Index > 30 kg/m2
- •drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive agent or adrenal cortex hormone)
- •pregnancy
- •acute coronary syndrome, acute myocardial infarction or undergone a revascularization procedure within 6 months
- •acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 3-fold the upper normal limit
- •nephrotic syndrome or serum creatinine (Cr) (≥179 µmol/L) and creatine •phosphokinase (CK) more than 3-fold the upper normal limit
- •primary hypothyroidism
- •psychiatric patients
- •poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg
- •Type I diabetes mellitus（DM）, poorly controlled Type II DM (BS>11.0 mmol/L ) or Type II DM with LDL-C >2.6 mmol/L.
- •using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs
研究组 & 干预措施
Coenzyme A 400mg
Coenzyme A 400mg per day
干预措施: Coenzyme A (Drug)
Fenofibrate 200mg
Fenofibrate 200mg per day
干预措施: Fenofibrate 200mg (Drug)
结局指标
主要结局
serum triglyceride level
时间窗: 10 months
The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.
次要结局
- serum total cholesterol level(10 months)
- low-density lipoprotein cholesterol level(10 months)
- serum high-density lipoprotein cholesterol level(10 months)
研究者
Jiangtao Lai
MD
Zhejiang University