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 —