Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia

Phase 4

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Lipid modification

• Registration Number: NCT01414803
• Lead Sponsor: Yonsei University

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 compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood glucose control, and blood cell counts.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-10
• Last Update Submitted: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rosuvastatin/fenofibrate combination	Lipid modification	rosuvastatin 10 mg/fenofibrate 160 mg per day
rosuvastatin monotherapy	Lipid modification	rosuvastatin 10 mg per day

Primary Outcome Measures

Name	Time	Method
Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN	24 weeks after drug treatment

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of