At a glance
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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
In Brief
A Phase 3 clinical trial evaluating EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg, and 3 other interventions for Hypercholesterolemia. Completed, enrolled 454 participants across 30 sites.
Detailed 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.
Study Details
Timeline
Interventions
FDC of EZ10 mg/Ator 10mg
FDC of EZ10 mg/Ator 20mg
Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
A single placebo tablet administered orally QD for 84 days
Two placebo tablets matching atorvastatin administered orally QD for 84 days