drugset / Trial / NCT00525824

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

NCT00525824

Phase 3 Completed 1743 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of \>20%

Timeline

Start
2007-08
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Subject Rosuvastatin Small molecule 10 mg
Subject Rosuvastatin Small molecule 20 mg
Subject Simvastatin Small molecule 40 mg
Subject Simvastatin Small molecule 80 mg