An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)

This study has been completed.
Sponsor:
Collaborator:
Institute of Applied Economics Aps, Denmark
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01077830
First received: February 26, 2010
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: December 16, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Cancer

  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
All participants from five countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who completed the SEAS base study and who were known to be alive at the end of the base study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1873 participants in the SEAS base study, 1392 were eligible for inclusion in this follow-up study. Of these 1392 participants, 33 were excluded due to incomplete base study data or because follow-up data could not be obtained, leaving 1359 participants in the follow-up study.

Reporting Groups
  Description
Ezetimibe/Simvastatin 10/40 mg Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
Placebo Participantss who received placebo in the base study

Participant Flow:   Overall Study
    Ezetimibe/Simvastatin 10/40 mg     Placebo  
STARTED     677     682  
COMPLETED     677     682  
NOT COMPLETED     0     0  



  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
Ezetimibe/Simvastatin 10/40 mg Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
Placebo Participants who received placebo in the base study
Total Total of all reporting groups

Baseline Measures
    Ezetimibe/Simvastatin 10/40 mg     Placebo     Total  
Number of Participants  
[units: participants]
  677     682     1359  
Age, Customized  
[units: Participants]
     
< 50 years     4     3     7  
50 to 59 years     92     91     183  
60 to 69 years     160     189     349  
70 to 79 years     250     234     484  
≥80 years     171     165     336  
Gender  
[units: Participants]
     
Female     267     272     539  
Male     410     410     820  



  Outcome Measures
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1.  Primary:   Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort   [ Time Frame: up to 21 Months after the end of the SEAS (base) study ]

2.  Secondary:   Crude Rate of Death (Any Cause) - Follow-up Total Cohort   [ Time Frame: up to 21 Months after the end of the base study ]

3.  Secondary:   Crude Rate of Death Due to Cancer - Follow-up Primary Cohort   [ Time Frame: up to 21 Months after the end of the base study ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077830     History of Changes
Other Study ID Numbers: 0653A-043-10, 2010_016
Study First Received: February 26, 2010
Results First Received: December 16, 2013
Last Updated: December 16, 2013
Health Authority: Denmark: Danish Medicines Agency