Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442897
First received: February 28, 2007
Last updated: November 19, 2013
Last verified: November 2013
Results First Received: October 1, 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
Patient were recruited between September 2006 and May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who were naïve to lipid-lowering agent or patients who were treated with lipid-lowering agent and had 4 week' wash-out period were enrolled in the study. The eligible patients will be allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio.

Reporting Groups
  Description
Vytorin Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
Atorvastatin Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.

Participant Flow for 2 periods

Period 1:   Base Study (12 Week Follow-up)
    Vytorin     Atorvastatin  
STARTED     118     111  
COMPLETED     101     99  
NOT COMPLETED     17     12  
Adverse Event                 1                 0  
Death                 0                 1  
Protocol Violation                 7                 3  
Withdrawal by Subject                 9                 8  

Period 2:   24 Weeks Follow-up (3 Centers)
    Vytorin     Atorvastatin  
STARTED     35 [1]   34 [2]
COMPLETED     29     28  
NOT COMPLETED     6     6  
Adverse Event                 1                 0  
Lost to Follow-up                 2                 2  
Protocol Violation                 2                 1  
Withdrawal by Subject                 1                 3  
[1] 66 Patients did not continue in the additional 12 week extension, for the 24 weeks follow-up period.
[2] 65 Patients did not continue in the additional 12 week extension, for the 24 weeks follow-up period.



  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.
No text entered.

Reporting Groups
  Description
Vytorin Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
Atorvastatin Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
Total Total of all reporting groups

Baseline Measures
    Vytorin     Atorvastatin     Total  
Number of Participants  
[units: participants]
  118     111     229  
Age  
[units: years]
Mean ± Standard Deviation
  60.89  ± 9.28     61.74  ± 9.94     61.30  ± 9.59  
Gender  
[units: participants]
     
Female     57     53     110  
Male     61     58     119  
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata  
[units: Participants]
     
LDL-C 130-159mg/dl     64     61     125  
LDL-C 160-189mg/dl     38     31     69  
LDL-C >=190mg/dl     16     18     34  
LDL-C <130mg/dl     0     1     1  
Baseline values for Apolipoprotein B (Apo B)  
[units: mg/dL]
Mean ± Standard Deviation
  113.23  ± 30.97     110.63  ± 31.63     111.97  ± 31.25  
Baseline values for High-Density Lipoprotein Cholesterol (HDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  48.23  ± 10.25     48.9  ± 13.01     48.55  ± 11.65  
Baseline values for LDL-C:HDL-C  
[units: Ratio]
Mean ± Standard Deviation
  3.54  ± 1.13     3.54  ± 1.04     3.54  ± 1.08  
Baseline values for Low-Density Lipoprotein Cholesterol(LDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  164.11  ± 33.52     162.56  ± 26.75     163.36  ± 30.37  
Baseline values for Non HDL-C  
[units: mg/dL]
Mean ± Standard Deviation
  191.54  ± 38.25     190.72  ± 31.11     191.14  ± 34.88  
Baseline values for Total Cholesterol (TC)  
[units: mg/dL]
Mean ± Standard Deviation
  241.4  ± 39.53     239.58  ± 30.86     240.51  ± 35.51  
Baseline values for Triglycerides (TG)  
[units: mg/dL]
Mean ± Standard Deviation
  142  ± 86.27     144  ± 57.34     143  ± 73.69  
Body Mass Index (BMI)  
[units: Kg/m2]
Mean ± Standard Deviation
  24.97  ± 2.92     24.86  ± 2.64     24.92  ± 2.78  
Body Weight  
[units: Kilograms (Kg)]
Mean ± Standard Deviation
  64.61  ± 9.78     64.40  ± 10.51     64.51  ± 10.12  
Diastolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  75.86  ± 10.16     77.74  ± 10.53     76.77  ± 15.98  
Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  126.44  ± 15.23     129.53  ± 16.65     127.94  ± 15.98  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment   [ Time Frame: After 6 weeks of treatment ]

2.  Secondary:   Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment   [ Time Frame: After 12 weeks of the treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442897     History of Changes
Other Study ID Numbers: 0653A-126, MK0653A-126, 2007_006
Study First Received: February 28, 2007
Results First Received: October 1, 2009
Last Updated: November 19, 2013
Health Authority: Korea: Food and Drug Administration