Overview

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-1

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
Merck Shering-Plough JV Study
Treatments:
Atorvastatin
Atorvastatin Calcium
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Simvastatin
Criteria
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