Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
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The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.
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Layout table for eligibility information
Ages Eligible for Study:
19 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aged between 19 and 75
Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl
Need drug therapy by NCEP ATP III guideline
Signed informed consent
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 use contraception while on study
Had participated other clinical trial within 4 weeks
Need systemic administration of corticosteroids intermittently