Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

Organon

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: simvastatin (+) ezetimibe; Drug: Comparator: atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442897

MK0653A-126

2007_006

0653A-126

Details and patient eligibility

About

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

Enrollment: 229 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are naïve to lowering lipid agent
• Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.

Exclusion criteria

• Impaired kidney function
• Increased liver enzyme levels
• Pregnant women
• Hypersensitivity to ezetimibe and other statin agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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229 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: simvastatin (+) ezetimibe

2

Active Comparator group

Treatment:

Drug: Comparator: atorvastatin