Status:
COMPLETED
Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia
Lead Sponsor:
Yonsei University
Conditions:
Hyperlipidemia
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief Summary
Although the combination of statin and fenofibrate is one of the options for patients with combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In this study we com...
Eligibility Criteria
Inclusion
- mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol levels higher than 130 mg/dL after 6-week diet/life style change
- Men and women who were between 20 and 70 years of age
- Having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus.
- Having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein (HDL)-cholesterol \<40 mg/dL, family history of coronary artery disease at age \<55 years in male or \<65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular hypertrophy on electrocardiogram
- Written informed consent.
Exclusion
- pregnant or breast-feeding
- uncontrolled hypertension
- uncontrolled diabetes mellitus
- thyroid dysfunction
- serum transaminase level \>2 times the upper limit of normal
- history of gall bladder disease
- chronic alcoholic
- serum creatinine level \>1.5 mg/dL
- history of myopathy
- history of acute myocardial infarction or acute stroke within 3 months before the study began
- acute or chronic infection or inflammation
- history of cancer
- history of adverse events associated with test drugs.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01414803
Start Date
March 1 2009
End Date
April 1 2011
Last Update
August 11 2011
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752