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)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition |
|---|
|
Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial |
- New Incidence of Cancer [ Time Frame: 21 Months after the end of the base study ] [ Designated as safety issue: Yes ]
- 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 ]
| Enrollment: | 1392 |
| Study Start Date: | March 2010 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01077830 History of Changes |
| Other Study ID Numbers: | MK-0653A-043-10, 2010_016 |
| Study First Received: | February 26, 2010 |
| Last Updated: | April 8, 2013 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Merck:
|
New Incidence of Cancer |
Additional relevant MeSH terms:
|
Simvastatin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013