Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

Organon and Co1,053 enrolled

Overview

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,053

Conditions

Hypercholesterolemia

Interventions

ezetimibe and atorvastatinDRUG

ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks

atorvastatinDRUG

Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks

Placebo (unspecified)DRUG

Placebo (unspecified) daily for 12 weeks

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is age 65 or older * Patient is willing to maintain cholesterol lowering diet * Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category Exclusion Criteria: * A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study * Patient is unlikely to be compliant in taking study medication * Patient with chronic or unstable medical condition * Patient is taking unstable doses of medication * Patient drinks more than 2 alcoholic drinks per day * Patient has elevations in certain laboratory values (CK, AST, ALT)

Outcomes

Primary Outcomes

Percent Change From Baseline in LDL-C at Week 6

Time frame: Baseline and Week 6

Secondary Outcomes

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

Time frame: Baseline and Week 12

Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6

Time frame: Week 6

Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12

Time frame: Week 12

Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6

Time frame: Week 6

Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12

Time frame: Week 12

Data from ClinicalTrials.gov

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