Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
- Registration Number
- NCT00973115
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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 will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simvastatin CR 20mg- evening administration Simvastatin CR - Simvastatin CR 20mg- morning administration Simvastatin CR -
- Primary Outcome Measures
Name Time Method the percent change from baseline in LDL cholesterol week 8
- Secondary Outcome Measures
Name Time Method the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a) week 8
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain Simvastatin CR's LDL-lowering effects in hyperlipidemia?
How does evening Simvastatin CR compare to standard statins in managing hyperlipidemia?
Are there specific biomarkers that predict response to Simvastatin CR in hyperlipidemic patients?
What are the potential adverse events associated with Simvastatin CR and their management strategies?
What combination therapies or competitor drugs are being studied alongside Simvastatin CR for hyperlipidemia?
Trial Locations
- Locations (1)
8 Sites
🇰🇷Seoul, Korea, Republic of
8 Sites🇰🇷Seoul, Korea, Republic of