Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 these two treatment options on small dense LDL-C (sdLDL-C) concentration have not been assessed.

The aim of the present study is to compare the effects of simvastatin 40 mg versus simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3 months after treatment initiation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ioannina
• Treatments: Ezetimibe; Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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