drugset / Trial / NCT01154036

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

NCT01154036

Phase 3 Completed 1547 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Timeline

Start
2010-07
Primary completion
2012-09
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg
Subject Atorvastatin Small molecule 20 mg
Subject Atorvastatin Small molecule 40 mg
Subject Ezetimibe Unknown 10 mg
Comparator Rosuvastatin Small molecule 10 mg
Comparator Rosuvastatin Small molecule 20 mg

Indications