At a glance
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A Phase III, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy and Safety of MK-0653C in Japanese Patients With Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating Ezetimibe 10 mg, Atorvastatin 10 mg, and 3 other interventions for Hypercholesterolemia. Completed, enrolled 309 participants.
Detailed Summary
This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe \[EZ\] 10 mg/Atorvastatin \[Atora\] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.
Study Details
Timeline
Interventions
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)