NCT02550288

A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)

A Phase III, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy and Safety of MK-0653C in Japanese Patients With Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe 10 mg
DRUG	Atorvastatin 10 mg
DRUG	Placebo for Ezetimibe 10 mg tablet
DRUG	Placebo for Atorvastatin 10 mg capsule
BEHAVIORAL	Diet control/Daily Exercise	Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Timeline

• Start date: 2015-09-29
• Primary completion: 2016-05-30
• Completion: 2016-05-30
• First posted: 2015-09-15
• Last updated: 2024-05-16
• Results posted: 2017-06-21