This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
Results First Received: September 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: simvastatin (+) ezetimibe
Drug: Comparator: atorvastatin

  Participant Flow
  Hide 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
  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
  Hide 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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 130   126   256 
Age 
[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
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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.
ClinicalTrials.gov Identifier: NCT00496730     History of Changes
Other Study ID Numbers: 0653A-129
MK0653A-129
2007_017
Study First Received: July 2, 2007
Results First Received: September 3, 2009
Last Updated: March 17, 2017