drugset / Trial / NCT00166530

EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)

NCT00166530

Phase 4 Completed 367 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (\> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.

Timeline

Start
2005-11
Primary completion
2007-02
Completion
2007-02

Drugs

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

Indications