Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 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

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 use contraception while on study

• Had participated other clinical trial within 4 weeks

• Need systemic administration of corticosteroids intermittently