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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496730
First received: July 2, 2007
Last updated: April 20, 2010
Last verified: April 2010
Results First Received: September 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: simvastatin (+) ezetimibe
Drug: Comparator: atorvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between June 2007 and May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who have Metabolic syndrome and Hypercholesterolemia had 4 weeks wash-out period were enrolled in this study. The eligible patients was allocated to one of Vytorin 10/20 mg or Atorvastatin 10 mg group.

Reporting Groups
  Description
Vytorin simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
Atorvastatin atorvastatin 10 mg; tablet, once daily, 8 Weeks

Participant Flow:   Overall Study
    Vytorin     Atorvastatin  
STARTED     130     126  
COMPLETED     124     121  
NOT COMPLETED     6     5  
Lost to Follow-up                 4                 3  
Withdrawal by Subject                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Vytorin simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
Atorvastatin atorvastatin 10 mg; tablet, once daily, 8 Weeks
Total Total of all reporting groups

Baseline Measures
    Vytorin     Atorvastatin     Total  
Number of Participants  
[units: participants]
  130     126     256  
Age  
[units: years]
Mean ± Standard Deviation
  58.96  ± 9.42     60.26  ± 9.44     59.61  ± 9.44  
Gender  
[units: participants]
     
Female     36     43     79  
Male     94     83     177  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  26.75  ± 3.59     26.45  ± 3.34     26.61  ± 3.46  
Diastolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  81.01  ± 8.47     82.11  ± 8.49     81.55  ± 8.48  
LDL-C (low-Density-Lipoprotein-Cholesterol)  
[units: mg/dL]
Mean ± Standard Deviation
  159.95  ± 30.33     159.95  ± 27.34     159.95  ± 28.84  
Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  130.81  ± 13.91     129.85  ± 14.51     130.34  ± 14.19  



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

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

3.  Other Pre-specified:   Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


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)