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

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Ezetimibe 10 mg/simvastatin 40 mg; Drug: Atorvastatin 20 mg; Drug: Atorvastatin 40 mg; Drug: Atorvastatin 10 mg; Drug: Ezetimibe 10 mg/simvastatin 20 mg

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00535405

0653A-128

2007_588

Details and patient eligibility

About

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.

Enrollment: 1,289 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,289 participants in 5 patient groups

1

Experimental group

Description:

Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Treatment:

Drug: Atorvastatin 10 mg

2

Experimental group

Description:

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Treatment:

Drug: Ezetimibe 10 mg/simvastatin 20 mg

3

Experimental group

Description:

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Treatment:

Drug: Atorvastatin 20 mg

4

Experimental group

Description:

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Treatment:

Drug: Ezetimibe 10 mg/simvastatin 40 mg

5

Experimental group

Description:

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Treatment:

Drug: Atorvastatin 40 mg