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

NCT ID: NCT01414803

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-04-30

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.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rosuvastatin/fenofibrate combination

rosuvastatin 10 mg/fenofibrate 160 mg per day

Group Type: EXPERIMENTAL

Lipid modification

Intervention Type: DRUG

rosuvastatin 10 mg/fenofibrate 160 mg per day

rosuvastatin monotherapy

rosuvastatin 10 mg per day

Group Type: ACTIVE_COMPARATOR

Lipid modification

Intervention Type: DRUG

rosuvastatin 10 mg per day

Interventions

Lipid modification

rosuvastatin 10 mg/fenofibrate 160 mg per day

Intervention Type: DRUG

Lipid modification

rosuvastatin 10 mg per day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Severance Hospital

Locations

Severance Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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. doi: 10.1046/j.1471-4159.2000.0751358.x.

Reference Type: BACKGROUND

PMID: 10987815 (View on PubMed)

Lee SH, Cho KI, Kim JY, Ahn YK, Rha SW, Kim YJ, Choi YS, Choi SW, Jeon DW, Min PK, Choi DJ, Baek SH, Kim KS, Byun YS, Jang Y. Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia. Atherosclerosis. 2012 Mar;221(1):169-75. doi: 10.1016/j.atherosclerosis.2011.12.042. Epub 2012 Jan 5.

Reference Type: DERIVED

PMID: 22269152 (View on PubMed)

Other Identifiers

4-2008-0390

Identifier Type: -

Identifier Source: org_study_id