Status:
COMPLETED
Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)
Lead Sponsor:
University of Ioannina
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential effects of the...
Detailed Description
Hypercholesterolemia is a major risk factor for atherosclerosis and coronary heart disease (CHD).\[1\] Epidemiological and clinical studies have demonstrated that aggressive lowering of low-density li...
Eligibility Criteria
Inclusion
- LDL-C levels above those recommended by the National Cholesterol Education
- Program Adult Treatment Panel III (NCEP-ATP III) based on each patient risk factors following a 3-month period of lifestyle changes.
Exclusion
- Triglycerides \>500 mg/dL, renal disease (serum creatinine levels \>1.6 mg/dL), hypothyroidism \[thyroid stimulating hormone (TSH) \>5 IU/mL\] and liver disease (ALT and/or AST levels \>3-fold upper limit of normal in 2 consecutive measurements).
- Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
- Patients currently taking lipid lowering drugs or having stopped them less than 4 weeks before study entry will be excluded
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00932620
Start Date
June 1 2009
End Date
April 1 2010
Last Update
August 19 2011
Active Locations (1)
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1
University Hospital of Ioannina
Ioannina, Ioannina, Greece, 45 110