Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)

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

Outcome

Met primary endpoint

registry analysis (other test); Atorvastatin 10 mg - Ezetimibe 10 mg/Ator 10 mg vs Atorvastatin 10mg - Atorvastatin 20 mg; p <0.001; NCT03768427 ↗

registry analysis (other test); Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg vs Atorvastatin 20 mg - Atorvastatin 40 mg; p <0.001; NCT03768427 ↗

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

Indications