NCT00479713

A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe (+) simvastatin	ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
DRUG	Comparator : rosuvastatin calcium	rosuvastatin 10mg. The treatment duration will be 6 weeks.
DRUG	Comparator: Placebo (unspecified)	rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
DRUG	Comparator: Placebo (unspecified)	ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-05-28
• Last updated: 2024-05-16
• Results posted: 2009-06-10