Phase 3
Completed N=618
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
Source: ClinicalTrials.gov NCT00479713 ↗Enrolled (actual)
618
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment — -27.66; -16.94 percent change from baseline — p=<=0.001
Summary
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment |
-27.66; -16.94 | <=0.001 sig |
| SECONDARY The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment |
72.46; 56.23; 25.25; 11.11 | <=0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant is currently taking a statin medication for the treatment of high cholesterol
- Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl
Exclusion Criteria
- Women who are pregnant or nursing, or women who intend to become pregnant
- Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study
Data sourced from ClinicalTrials.gov (NCT00479713). 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.