A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

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

Inclusion criteria

• ≥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.

Exclusion criteria

• 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