Status:
COMPLETED
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Lead Sponsor:
Abbott
Collaborating Sponsors:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Conditions:
Dyslipidemias
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 publish...
Detailed Description
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/...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT01462877
Start Date
October 1 2011
End Date
March 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
Site Reference ID/Investigator# 64695
Xiamen, China, 36100