Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Screening visit (Pre-Study Visit :D-28)

Men and women at the age ≥ 20 and < 80

Patients at a high risk of coronary heart disease according to the NCEP ATPIII guidelines

Patients with coronary artery disease, or
Patients with symptomatic carotid artery disease, or
Patients with peripheral vascular disease, or
Patients with abdominal aneurysm, or
Patients with diabetes mellitus, or
Patients at a more than 20% 10-year risk of coronary heart disease, or
LDL-C < 160mg/dL at screening
Fasting triglyceride (TG) level ≥ 150mg/dL and < 500mg/dL at screening
HDL-C level <40mg/dL (Male Patient), <50mg/dL(Female Patient)
Voluntary written informed consent to study participation

Secondary visit (Visit 2 (D0))

LDL-C < 100mg/dL after the 4-week atorvastatin run-in period
Fasting TG level ≥ 150mg/dL and < 500mg/dL after the 4-week atorvastatin run-in period
HDL-C level <40mg/dL (Male Patient), <50mg/dL(Female Patient)

Exclusion Criteria:

Acute arterial disease (history of unstable angina pectoris, myocardial infarction, acute coronary syndrome, transient ischemic attack, cerebrovascular disease, coronary bypass, or coronary artery disease within 3 months prior to study participation)
Revascularzation procedure or aortic aneurysm operation within 6 months prior to study participation
Myopathy, history of rhabdomyolysis or myopathy due to statins or fibrates, or elevated CK level ≥ 5 x upper limit of normal (ULN) during the previous statin treatment
Acute or chronic pancreatitis due to hypertriglyceridemia
Cardiovascular, hepatic, neurological, endocrine, or other serious systemic disease that may affect the study conduct or interpretations of the study results
Known positive serum tests to human immunodeficiency virus (HIV) Antibody I or II
Diagnosis of cancer within the past 2 years (except successfully treated basal cell carcinoma and squamous cell carcinoma)
Patients treated with prohibited concomitant medications during the study period or those for whom treatment with prohibited concomitant medications is considered inevitable (systemic or inhalant corticosteroids may be allowed during the study provided that the treatment is maintained at the same dose.)
Administration of or will be administered with periodic sex hormone therapies or oral contraceptives within 2 months prior to the screening visit or during the study participation
Moderate to severe renal impairment (GFR<60ml/min) at screening
Severe hepatic impairment with AST/ALT level > 3 x ULN at screening (biliary cirrhosis, active liver disease, or continued increases in transaminases by unknown causes (> 3 x ULN), etc.)
Uncontrolled hypothyroidism
Uncontrolled diabetes mellitus (HbA1c>8.5%)
Hyperlipidemia Class I, IIa, IV, or V
Requiring insulin treatment for diabetes mellitus
Allergies or hypersensitivity reactions to the study drug
Patients known to have, or suspected of having a history of drug or alcohol abuse within the past 2 years
Confirmed pregnant or lactating women at screening
Women of childbearing potential at screening and planning to become pregnant during the study. Women at the childbearing age who did not undergo surgical sterilization may participate in the study only if the pregnancy test is determined negative and should maintain effective contraceptive methods throughout the study period. Periodic abstinence (e.g., calendar method, ovulation method, symptothermal method, post-ovulation method) and self control are not considered to be acceptable contraceptive methods, and use of hormonal contraceptives is not allowed.
Having participated in another clinical trial within 1 month prior to screening
History of photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen
Biliary disease
Interstitial pulmonary disease
Other patients considered by the principal investigator or sub-investigator inappropriate for study participation