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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: ezetimibe and atorvastatin; Drug: atorvastatin; Drug: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418834

MK0653-112

0653-112

2006_549

Details and patient eligibility

About

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.

Enrollment: 1,053 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,053 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: Placebo (unspecified)

Drug: ezetimibe and atorvastatin

2

Active Comparator group

Treatment:

Drug: Placebo (unspecified)

Drug: atorvastatin