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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01414803
First received: August 3, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Hyperlipidemia
Drug: Lipid modification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN [ Time Frame: 24 weeks after drug treatment ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: March 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414803

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yangsoo Jang/Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01414803     History of Changes
Other Study ID Numbers: 4-2008-0390
Study First Received: August 3, 2011
Last Updated: August 10, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Rosuvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014