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

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin (+) ezetimibe

Drug

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

Other names: MK0653A, Vytorin®

Comparator: atorvastatin

Drug

atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)

Other names: Lipitor®

Primary outcomes

Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment

Time frame: 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)

Secondary outcomes

Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment

Time frame: After 12 weeks of the 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Mar 5, 2007
Registry last updated: May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed