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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01414803
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Lipid modification Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: rosuvastatin/fenofibrate combination
rosuvastatin 10 mg/fenofibrate 160 mg per day
Drug: Lipid modification
rosuvastatin 10 mg/fenofibrate 160 mg per day

Active Comparator: rosuvastatin monotherapy
rosuvastatin 10 mg per day
Drug: Lipid modification
rosuvastatin 10 mg per day

Primary Outcome Measures :
  1. Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN [ Time Frame: 24 weeks after drug treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01414803

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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yangsoo Jang/Professor, Severance Hospital Identifier: NCT01414803    
Other Study ID Numbers: 4-2008-0390
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011
Keywords provided by Yonsei University:
rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases