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

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Lipid modification

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rosuvastatin/fenofibrate combination

rosuvastatin monotherapy

Arm Description

rosuvastatin 10 mg/fenofibrate 160 mg per day

rosuvastatin 10 mg per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01414803

First Posted

August 3, 2011

Last Updated

August 10, 2011

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01414803

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

Keywords

rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rosuvastatin/fenofibrate combination

Arm Type

Experimental

Arm Description

rosuvastatin 10 mg/fenofibrate 160 mg per day

Arm Title

rosuvastatin monotherapy

Arm Type

Active Comparator

Arm Description

rosuvastatin 10 mg per day

Intervention Type

Drug

Intervention Name(s)

Lipid modification

Intervention Description

rosuvastatin 10 mg/fenofibrate 160 mg per day

Intervention Type

Drug

Intervention Name(s)

Lipid modification

Intervention Description

rosuvastatin 10 mg per day

Primary Outcome Measure Information:

Title

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

Time Frame

24 weeks after drug treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

10987815

Citation

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.

Results Reference

background

PubMed Identifier

22269152

Citation

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.

Results Reference

derived

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

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