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

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414803
• Other study ID #: 4-2008-0390
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2011
• Last updated: August 10, 2011
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: August 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Lipid modification
rosuvastatin 10 mg/fenofibrate 160 mg per day
• Lipid modification
rosuvastatin 10 mg per day

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN		24 weeks after drug treatment	No