Status:
COMPLETED
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Hyperlipidemia
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00973115
Start Date
November 1 2007
End Date
August 1 2009
Last Update
October 12 2016
Active Locations (1)
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1
8 Sites
Seoul, South Korea