Phase 4
Completed N=100
Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)
Source: ClinicalTrials.gov NCT00932620 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels — -42; -46 sdLDL-C, mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels |
-42; -46 | — |
| SECONDARY Changes in Low-density Lipoprotein Cholesterol (LDL-C) |
-43; -49 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00932620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.