MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Summary
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Timeline
- Start
- 2010-07
- Primary completion
- 2012-09
- Completion
- 2012-10
Outcome
Met primary endpoint
registry analysis (unspecified test); Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg vs Phase I: Atorvastatin 20 mg; p <0.001; NCT01154036 ↗
registry analysis (unspecified test); Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg vs Phase I: Rosuvastatin 10 mg; p <0.001; NCT01154036 ↗
Publications
- Krempf M, Simpson RJ Jr, Ramey DR, Brudi P, Giezek H, Tomassini JE, Lee R, Farnier M. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015 May 19;14:45. doi: 10.1186/s12944-015-0037-y.
- Bays HE, Averna M, Majul C, Muller-Wieland D, De Pellegrin A, Giezek H, Lee R, Lowe RS, Brudi P, Triscari J, Farnier M. Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol. 2013 Dec 15;112(12):1885-95. doi: 10.1016/j.amjcard.2013.08.031. Epub 2013 Sep 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 10 mg | — |
| Subject | Atorvastatin | Small molecule | 20 mg | — |
| Subject | Atorvastatin | Small molecule | 40 mg | — |
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Comparator | Rosuvastatin | Small molecule | 10 mg | — |
| Comparator | Rosuvastatin | Small molecule | 20 mg | — |