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)

Organon and Co1,289 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,289

Conditions

Hypercholesterolemia

Interventions

Atorvastatin 10 mgDRUG

Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Ezetimibe 10 mg/simvastatin 20 mgDRUG

Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks

Atorvastatin 20 mgDRUG

Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has a cholesterol level of 130 mg/dL or greater * Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study * Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines Exclusion Criteria: * Patient weighs less than 100 lbs * Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Outcomes

Primary Outcomes

Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

Time frame: Baseline and 12 weeks

Secondary Outcomes

Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12

Time frame: 12 weeks

Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

Time frame: 12 Weeks

Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12

Time frame: 12 Weeks

Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12

Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.

Time frame: 12 Weeks

Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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