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

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ClinicalTrials.gov Identifier: NCT00442897
Recruitment Status : Completed
First Posted : March 5, 2007
Results First Posted : November 9, 2009
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: simvastatin (+) ezetimibe Drug: Comparator: atorvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442897


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442897     History of Changes
Other Study ID Numbers: 0653A-126
MK0653A-126
2007_006
First Posted: March 5, 2007    Key Record Dates
Results First Posted: November 9, 2009
Last Update Posted: April 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Keywords provided by Merck Sharp & Dohme Corp.:
Hypercholesterolaemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors