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: June 16, 2014
Last verified: June 2014

February 26, 2010
June 16, 2014
March 2010
February 2013   (final data collection date for primary outcome measure)
Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort [ Time Frame: up to 21 Months after the end of the SEAS (base) study ] [ Designated as safety issue: Yes ]
Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.
New Incidence of Cancer [ Time Frame: 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01077830 on ClinicalTrials.gov Archive Site
  • Crude Rate of Death (Any Cause) - Follow-up Total Cohort [ Time Frame: up to 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
    All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.
  • Crude Rate of Death Due to Cancer - Follow-up Primary Cohort [ Time Frame: up to 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
    All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.
  • 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 ]
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)
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. At the time of Follow-up study initiation, accessing the registry data in Ireland was not feasible due to local regulations and Cancer and Death registries did not exist in 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1392
April 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
0653A-043-10, 2010_016
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Institute of Applied Economics Aps, Denmark
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

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