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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496730
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : November 17, 2009
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: simvastatin (+) ezetimibe
Drug: Comparator: atorvastatin

  Participant Flow

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
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 
Lost to Follow-up                4                3 
Withdrawal by Subject                2                2 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 130   126   256 
[Units: Years]
Mean (Standard Deviation)
 58.96  (9.42)   60.26  (9.44)   59.61  (9.44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      36  27.7%      43  34.1%      79  30.9% 
Male      94  72.3%      83  65.9%      177  69.1% 
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

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

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

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00496730     History of Changes
Other Study ID Numbers: 0653A-129
First Submitted: July 2, 2007
First Posted: July 4, 2007
Results First Submitted: September 3, 2009
Results First Posted: November 17, 2009
Last Update Posted: April 14, 2017