An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Percentage of Triglyceride (TG) Change
研究概览
简要总结
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.
详细描述
It is an open-label , single group, multi-center study. At around 30 investigate sites, 500 dyslipidemic Chinese patients with coronary heart disease (CHD) or CHD risk equivalent, whose TG ≥1.70 mmol/L (150mg/dl) and <5.65mmol/L (500mg/dl) after at least 2 month statin monotherapy with standard dose will be enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG will be recruited and given statin-fenofibrate combination therapy for 8 weeks. Several lipid parameters and safety parameters will be compared between baseline, after 4 weeks treatment and after 8 weeks treatment. Primary efficacy endpoint is the percentage of TG decrease before and after 8 weeks treatment. Secondary endpoints on efficacy are the absolute change and the percent of change on TC, LDL-C, HDL-C, apoA1, apoB and apoB/apoA1 of baseline, after 4 weeks treatment and 8 weeks treatment, absolute change and percentage of change of hsCRP from baseline to 8 weeks of treatment. Second endpoints on safety is the incidence of AE/SAE, change on CK, ALT, AST, BUN and Cr before and after treatment and the number of clinical meaningful abnormal change defined as ALT or AST >3ULN, or CK >10ULN, or BUN >1.5ULN or Cr >1.5ULN. Other Arm type is a self comparator
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years and < 80 years, male or female
- •With at least one risk of coronary heart disease (CHD) [medical history of myocardial infarction (MI) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (PCI) or post coronary artery bypass grafting (CABG)] or CHD risk equivalents, which comprise,
- •Other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease)
- •Type 2 Diabetes
- •Multiple risk factors that confer a 10-year risk for CHD >20%.
- •≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin
- •Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl)
- •Subject must be able to provide informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), on his or her own behalf, prior to any study-specific procedures.
排除标准
- •Hypersensitive to fenofibrate or to any of its excipients
- •Hepatic insufficiency [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2ULN (upper limit of normal)]
- •Renal insufficiency [Creatinine clearance rate (Ccr)<60ml/min estimated from Cockcroft-Gault equation Ccr=(140-age)*weight(Kg)*0.85(if female)/[0.818*Cr (µmol/L)]
- •Creatine kinase (CK) > 2 ULN
- •Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
- •Hypothyroidism
- •Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
- •Combination use of drug with similar structure as Fenofibrate, especially ketoprofen
- •Combination use of oral anticoagulants
- •Pregnant or lactating woman
- •Other conditions at investigator's discretion
研究组 & 干预措施
Fenofibrate arm
干预措施: fenofibrate (Drug)
结局指标
主要结局
Percentage of Triglyceride (TG) Change
时间窗: Baseline and up to 8 weeks after intervention
Blood tests
次要结局
- Change in Serum Total Cholesterol(Baseline and up to 8 weeks after intervention)
- Change in Serum Low-density Lipoprotein Cholesterol(Baseline up to 8 weeks after intervention)
- Change in Serum High-density Lipoprotein Cholesterol(Baseline up to 8 weeks after intervention)
- Change in Serum Non-high-density Lipoprotein Cholesterol(Baseline up to 8 weeks after intervention)
- Change in Serum Apolipoprotein A1(Baseline up to 8 weeks after intervention)
- Change in Serum Apolipoprotein B(Baseline up to 8 weeks after intervention)
- Change in Serum Alanine Aminotransferase(Baseline up to 8 weeks after intervention)
- Change in Serum Aspartate Aminotransferase(Baseline up to 8 weeks after intervention)
- Change in Serum Creatine Kinase(Baseline up to 8 weeks after intervention)
- Change in Serum Creatinine(Baseline up to 8 weeks after intervention)
- Change in Serum High Sensitivity C-reactive Protein(Baseline and up to 8 weeks after intervention)