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OpenTrials
Completed

NCT Number: NCT01414803

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipid modification

Drug

rosuvastatin 10 mg/fenofibrate 160 mg per day

Primary outcomes

  1. Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN

    Time frame: 24 weeks after drug treatment

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2011
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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