Phase
Condition
Dyslipidemia
Elevated Triglycerides (Hypertriglyceridemia)
Hypertriglyceridemia
Treatment
N/AClinical Study ID
Ages 19-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged between 19 and 75
Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400mg/dl
Need drug therapy by NCEP ATP III guideline
Signed informed consent
Exclusion
Exclusion Criteria:
Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
Has a presence or history of alcohol abuse or drug abuse
Active gallbladder disease within 12 months
Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL)
HbA1c≥ 9% in type 2 diabetes mellitus patients
SBP < 90mmHg or > 160mmHg
DBP < 50mmHg or > 100mmHg
Myocardial infarction or revascularization procedure within 6 months
Has significant cardiovascular disease
Malignant tumor within 5years
Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
Uric acid level > 9 mg/dl
Thyroid stimulating hormone ≥ 2XUNL
Active peptic ulcer disease
CPK levels > 3XUNL
creatinine level > 2 mg/dl
Negative pregnancy test for women of childbearing age and agreement to usecontraception while on study
Had participated other clinical trial within 4 weeks
Need systemic administration of corticosteroids intermittently
Study Design
Connect with a study center
8 Sites
Seoul,
Korea, Republic ofSite Not Available
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