NCT00535405

A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,289 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin 10 mg	Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
DRUG	Ezetimibe 10 mg/simvastatin 20 mg	Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
DRUG	Atorvastatin 20 mg	Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
DRUG	Ezetimibe 10 mg/simvastatin 40 mg	Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
DRUG	Atorvastatin 40 mg	Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-09-26
• Last updated: 2024-05-16
• Results posted: 2010-05-25