drugset / Trial / NCT03768427
Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in LDL-C to 12 weeks after treatment.
Timeline
- Start
- 2019-05-27
- Primary completion
- 2021-03-17
- Completion
- 2021-04-01
Publications
- Qian J, Zhang X, Chen J, Ding C, Yang P, Qing L, Liu Y, Chen SS, Ge J. LDL-C Goal Attainment with Fixed-Dose Ezetimibe and Atorvastatin Versus High-Dose Atorvastatin in Chinese Patients: Subgroup Analysis of a Randomized Trial. Adv Ther. 2026 Mar;43(3):1187-1198. doi: 10.1007/s12325-025-03429-8. Epub 2026 Jan 19.
- Qian J, Li Z, Zhang X, Chen J, Ding C, Yang P, Liu Y, Shi M, Ren X, Ge J; Phase III Study Investigators. Efficacy and Tolerability of Ezetimibe/Atorvastatin Fixed-dose Combination Versus Atorvastatin Monotherapy in Hypercholesterolemia: A Phase III, Randomized, Active-controlled Study in Chinese Patients. Clin Ther. 2022 Oct;44(10):1282-1296. doi: 10.1016/j.clinthera.2022.08.013. Epub 2022 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atorvastatin | Small molecule | 10 mg | Oral |
| Comparator | Atorvastatin | Small molecule | 20 mg | Oral |
| Comparator | Atorvastatin | Small molecule | 40 mg | Oral |
| Subject | Ezetimibe | Unknown | 10 mg | Oral |