Phase 3
Completed N=1,220
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Source: ClinicalTrials.gov NCT00271817 ↗Enrolled (actual)
1,220
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) — -20.1; -58.5 Percent change — p=<0.001
Summary
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) |
-53.5; -58.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) |
-47.9; -55.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) |
9.0; 30.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) |
-26.8; -44.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) |
-53.5; -58.5 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
- Patient willing to be on a low-cholesterol diet
Exclusion Criteria
- Pregnant or lactating women or intending to become pregnant
- Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
- Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
- Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
Data sourced from ClinicalTrials.gov (NCT00271817). 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.