drugset / Trial / NCT00871351

Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

NCT00871351

Phase 4 Completed 125 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Timeline

Start
2009-02-01
Primary completion
2010-05-01
Completion
2010-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 10 mg
Comparator Atorvastatin Small molecule 20 mg
Subject Ezetimibe Unknown 10 mg
Comparator Rosuvastatin Small molecule 2.5 mg

Indications