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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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00496730
First received: July 2, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia
 Drug: simvastatin (+) ezetimibe
Drug: Comparator: atorvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 256
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496730

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
(MedWatch - FDA maintained medical product safety Information)  This link exits the ClinicalTrials.gov site
(Merck: Patient & Caregiver U.S. Product Web Site)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00496730     History of Changes
Other Study ID Numbers: 2007_017, MK0653A-129
Study First Received: July 2, 2007
Results First Received: September 3, 2009
Last Updated: April 20, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Merck:
Metabolic Disorder

Additional relevant MeSH terms:
Hypercholesterolemia
Metabolic Syndrome X
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Simvastatin
Atorvastatin
 Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013