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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496730
First received: July 2, 2007
Last updated: March 17, 2017
Last verified: March 2017
July 2, 2007
March 17, 2017
July 2007
August 2008   (Final data collection date for primary outcome measure)
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. [ Time Frame: Baseline and 8 Weeks ]
Mean percent change from baseline in LDL-C
Complete list of historical versions of study NCT00496730 on ClinicalTrials.gov Archive Site
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).

Not Provided
Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. [ Time Frame: Baseline and Week 8 ]
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: simvastatin (+) ezetimibe
    simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
    Other Names:
    • MK0653A
    • Vytorin®
  • Drug: Comparator: atorvastatin
    atorvastatin 10 mg; tablet, once daily, 8 Weeks
    Other Name: Lipitor®
  • Experimental: Vytorin®
    simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
    Intervention: Drug: simvastatin (+) ezetimibe
  • Active Comparator: atorvastatin
    atorvastatin 10 mg; tablet, once daily, 8 Weeks
    Intervention: Drug: Comparator: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Korea, Republic of
 
NCT00496730
0653A-129
MK0653A-129
2007_017
Not Provided
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP