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A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00496730
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : November 17, 2009
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: simvastatin (+) ezetimibe Drug: Comparator: atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea
Study Start Date : July 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008


Arm Intervention/treatment
Experimental: Vytorin®
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
Drug: simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
Other Names:
  • MK0653A
  • Vytorin®
Active Comparator: atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
Drug: Comparator: atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
Other Name: Lipitor®



Primary Outcome Measures :
  1. Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. [ Time Frame: Baseline and 8 Weeks ]

Secondary Outcome Measures :
  1. Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. [ Time Frame: Baseline and 8 weeks ]

    Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.

    LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).



Other Outcome Measures:
  1. Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. [ Time Frame: Baseline and Week 8 ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
  • No history of diabetes and 100 <=LDL-C <=250 mg/dl

Exclusion Criteria:

  • Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
  • Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Uncontrolled hypertension
  • Unstable angina

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): NCT00496730


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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00496730     History of Changes
Other Study ID Numbers: 0653A-129
MK0653A-129
2007_017
First Posted: July 4, 2007    Key Record Dates
Results First Posted: November 17, 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.:
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Syndrome X
Hypercholesterolemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
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