Status:
COMPLETED
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1053 Patients enrolled
Trial Details
Trial ID
NCT00418834
Start Date
January 1 2007
End Date
October 1 2008
Last Update
May 14 2024
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