NCT03768427

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

A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	EZ 10 mg/Ator 10 mg	FDC of EZ10 mg/Ator 10mg
COMBINATION_PRODUCT	EZ 10 mg/Ator 20 mg	FDC of EZ10 mg/Ator 20mg
DRUG	Atorvastatin	Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
DRUG	Placebo for FDC EZ/Ator	A single placebo tablet administered orally QD for 84 days
DRUG	Placebo for atorvastatin	Two placebo tablets matching atorvastatin administered orally QD for 84 days

Timeline

• Start date: 2019-05-27
• Primary completion: 2021-03-17
• Completion: 2021-04-01
• First posted: 2018-12-07
• Last updated: 2024-05-16
• Results posted: 2023-02-08

Locations

30 sites across 1 country: China