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NCT00442897 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00442897
Other study ID # 0653A-126
Secondary ID MK0653A-1262007_
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2006
Est. completion date October 2008

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 229
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
• Comparator: atorvastatin
atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg) After 6 weeks of treatment
Secondary Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. After 12 weeks of the treatment
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