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)
2022年2月7日 更新者：Organon and Co
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).
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
1392
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort
大体时间：up to 21 Months after the end of the SEAS (base) study
|
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.
|
up to 21 Months after the end of the SEAS (base) study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Crude Rate of Death (Any Cause) - Follow-up Total Cohort
大体时间：up to 21 Months after the end of the base study
|
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.
|
up to 21 Months after the end of the base study
|
|
Crude Rate of Death Due to Cancer - Follow-up Primary Cohort
大体时间：up to 21 Months after the end of the base study
|
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.
|
up to 21 Months after the end of the base study
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年3月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年4月1日
研究注册日期
首次提交
2010年2月26日
首先提交符合 QC 标准的
2010年2月26日
首次发布 (估计)
2010年3月1日
研究记录更新
最后更新发布 (实际的)
2022年2月9日
上次提交的符合 QC 标准的更新
2022年2月7日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
其他研究编号
- 0653A-043-10
- 2010_016 (其他标识符：Merck Registration Number)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.