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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 AM1)

This study has been completed.
Sponsor:
Collaborator:
Institute of Applied Economics Aps, Denmark
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01077830
First received: February 26, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes

February 26, 2010
April 8, 2013
March 2010
February 2013   (final data collection date for primary outcome measure)
New Incidence of Cancer [ Time Frame: 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01077830 on ClinicalTrials.gov Archive Site
  • Total number of patients who died [ Time Frame: 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
  • Number of patients who died due to cancer [ Time Frame: 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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 AM1)
A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial

The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004_050, MK0653A-043; NCT00092677).

The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050, MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. No patient visits will occur. National cancer and death registries exist in 5 of the 7 countries that participated in the base SEAS trial. Registries do not exist in Ireland and Germany. As a result, data will be collected only for all SEAS patients known to be alive at the end of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study.
Cancer
Not Provided
  • 1
    Subjects who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study
  • 2
    Subjects who were assigned to the placebo cohort in the base study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1392
March 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study
Both
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077830
MK-0653A-043-10, 2010_016
No
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck
Institute of Applied Economics Aps, Denmark
Study Director: Medical Monitor Merck
Merck
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP