NCT00651378

Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)

An Open-Label, Randomized, Parallel-Group, Multicenter Study to Compare the Efficacy and Safety of "Switching" to Rosuvastatin 10 mg Daily Versus Atorvastatin 10 mg Daily With Ezetimibe 10 mg Daily Versus Doubling the Dose of Atorvastatin to 20 mg Daily in Subjects With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease or Diabetes Mellitus Who Have Not Achieved Study Target LDL-C Goal While Dosing With Atorvastatin 10 mg Daily

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of \<2.5 mmol/L. Treatment phase is 6 weeks.

Conditions

• Hypercholesterolemia
• Atherosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin	oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
DRUG	Ezetimibe + Atorvastatin	oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
DRUG	Double Atorvastatin	oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)

Timeline

• Start date: 2004-09-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2008-04-02
• Last updated: 2024-08-15