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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: February 28, 2007
Last updated: November 18, 2015
Last verified: November 2015
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

Condition Intervention Phase
Drug: simvastatin (+) ezetimibe
Drug: Comparator: atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment [ Time Frame: After 12 weeks of the treatment ] [ Designated as safety issue: No ]
    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.

Enrollment: 229
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
Other Names:
  • MK0653A
  • Vytorin®
Active Comparator: 2 Drug: Comparator: atorvastatin
atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
Other Name: Lipitor®


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00442897

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442897     History of Changes
Other Study ID Numbers: 0653A-126  MK0653A-126  2007_006 
Study First Received: February 28, 2007
Results First Received: October 1, 2009
Last Updated: November 18, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2016