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A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments.
This study has been completed.
Study NCT00462748   Information provided by Merck

First Received on April 18, 2007.   Last Updated on April 20, 2010   History of Changes
Results First Received: May 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin
Drug: Comparator: rosuvastatin

  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 with diabetes, cardiovascular disease (CVD) or a “high risk” of developing CVD and a fasting LDL-C level of ≥2mmol/l, having been on simvastatin 40mg for 6 weeks were assigned to 10/40 mg ezetimibe/simvastatin; 40 mg atorvastatin; 10 mg rosuvastatin (5 mg in elderly/Asian patients (in line with UK SPC)) between 27/03/2007 and 31/03/2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were subjected to a 6 week run-in period on open label 40 mg simvastatin to stabilise their LDL-C levels. Patients whose LDL-C at the end of this period was below 2.0 mmol/l or who were <75% compliant with run-in medication, were excluded from the study

Reporting Groups
  Description
Ezetimibe/Simvastatin ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
Atorvostatin atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Rosuvastatin rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally

Participant Flow:   Overall Study
    Ezetimibe/Simvastatin     Atorvostatin     Rosuvastatin  
STARTED     261     263     262  
COMPLETED     249     252     251  
NOT COMPLETED     12     11     11  
Adverse Event                 7                 5                 9  
Protocol Violation                 0                 2                 1  
Withdrew consent                 3                 3                 0  
Lost to Follow-up                 1                 1                 1  
Discontinued after 41 days Rx                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Ezetimibe/Simvastatin ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
Atorvostatin atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Rosuvastatin rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally

Baseline Measures
    Ezetimibe/Simvastatin     Atorvostatin     Rosuvastatin     Total  
Number of Participants  
[units: participants]
  261     263     262     786  
Age  
[units: years]
Mean ± Standard Deviation
  64.7  ± 8.65     64.2  ± 8.44     63.9  ± 8.61     64.3  ± 8.56  
Age, Customized  
[units: participants]
       
< 70 years     185     187     195     567  
>=70 years     76     76     67     219  
Gender  
[units: participants]
       
Female     101     78     84     263  
Male     160     185     178     523  
Race/Ethnicity, Customized  
[units: Participants]
       
Asian     3     0     2     5  
White     254     261     257     772  
Black     4     0     2     6  
Other     0     2     1     3  



  Outcome Measures

1.  Primary:   Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End   [ Time Frame: 6 Weeks ]


  Serious Adverse Events
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  Other Adverse Events
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  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
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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 by Merck

Publications automatically indexed to this study:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00462748     History of Changes
Other Study ID Numbers: 2007_013, MK0653A-121
Study First Received: April 18, 2007
Results First Received: May 7, 2009
Last Updated: April 20, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency