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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Rundo International Pharmaceutical Research & Development Co.,Ltd.
• Treatments: Fenofibrate; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

Inclusion Criteria:

1. ≥18 years and < 80 years, male or female

2. 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%.

3. ≥ 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

4. Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl)

5. 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:

1. Hypersensitive to fenofibrate or to any of its excipients

2. Hepatic insufficiency [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2ULN (upper limit of normal)]

3. 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)]

4. Creatine kinase (CK) > 2 ULN

5. Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency

6. Hypothyroidism

7. Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months

8. Combination use of drug with similar structure as Fenofibrate, especially ketoprofen

9. Combination use of oral anticoagulants

10. Pregnant or lactating woman

11. Other conditions at investigator's discretion