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Clinical trial

Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease

ID
Name
0653A-126
Description
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
Trial arms
Trial start
2006-09-01
Estimated PCD
2008-10-01
Trial end
2008-10-01
Status
Completed
Phase
Early phase I
Treatment
simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
Arms:
1
Other names:
MK0653A, Vytorin®
Comparator: atorvastatin
atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
Arms:
2
Other names:
Lipitor®
Size
229
Primary endpoint
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
After 6 weeks of treatment
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 229, 'type': 'ACTUAL'}}
Updated at
2024-05-22

1 organization

2 products

1 indication

Organization
Organon and Co
Product
Simvastatin + Ezetimibe
Indication
Hypercholesterolemia
Product
Atorvastatin