drugset / Trial / NCT00479713
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)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
Timeline
- Start
- 2007-02-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN Ezetemibe + Simvastatin: -27.66 (-30.27 to -25.04) percent change from baseline NCT00479713 ↗
registry analysis (unspecified test); Ezetemibe + Simvastatin vs Rosuvastatin; p <=0.001; Mean Difference (Final Values) -10.72 (95% CI -14.10 to -7.33); ANOVA NCT00479713 ↗
Publications
- Background Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. doi: 10.1111/j.1742-1241.2009.02022.x. Epub 2009 Feb 16.
- Averna M, Missault L, Vaverkova H, Farnier M, Viigimaa M, Dong Q, Shah A, Johnson-Levonas AO, Taggart W, Brudi P. Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome. Diab Vasc Dis Res. 2011 Oct;8(4):262-70. doi: 10.1177/1479164111418136. Epub 2011 Aug 22.
- Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P. Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency. Lipids Health Dis. 2010 Nov 4;9:127. doi: 10.1186/1476-511X-9-127.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Comparator | Rosuvastatin | Small molecule | 10 mg | — |
| Subject | Simvastatin | Small molecule | 20 mg | — |