A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
- Registration Number
- NCT00566267
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Moderately obese with hyperlipidemia
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Exclusion Criteria
- Recent unstable heart or lung condition
- Current use of other lipid modifying drugs
- Hepatic disease
- Pregnancy or lactation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 simvastatin 20 mg/ezetimibe Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg
- Primary Outcome Measures
Name Time Method LDL cholesterol 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Other lipid measures 8 weeks of treatment Safety and tolerability 8 weeks treatment