Cardiovascular Events in Parkinson's Disease Patients
2017年5月15日 更新者：GlaxoSmithKline
Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database
Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD).
The background incidence rate of CV events in a levodopa-treated PD population was assessed to better understand these comorbidities in the PD population.
One objective of the study is to identify a population of prevalent PD patients with incident levodopa use within the years 2004-2010 on the Integrated Health Care Information Services (IHCIS) database.
The second objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and 12-18 months after first prescription of levodopa among all new levodopa users.
研究概览
研究类型
观察性的
注册 (实际的)
1
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
20年 及以上 (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 study cohorts of interest will be identified from the most recent datacut of the IHCIS database.
Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010 will be included.
The date of the first prescription of levodopa in the study time period is defined as the INDEX DATE.
All individuals must be on the database with medical and pharmacy benefit for at least 6 months prior to the INDEX DATE.
All individuals must have one or more diagnosis codes for Parkinson's disease within the 6 months prior or 6 months post INDEX DATE.
Individuals will be excluded if age is <20 years on the INDEX date.
Individuals will also be excluded if they have a previous levodopa prescription prior to the INDEX date as only new users of levodopa are of interest.
描述
Inclusion Criteria:
- Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010
- Individuals on the database with medical and pharmacy benefit for at least 6 months prior to date of first prescription of levodopa
- Individuals with one or more diagnosis codes for Parkinson's disease within the 6 months prior or 6 months post first prescription of levodopa
Exclusion Criteria:
- Individuals less than 20 years of age on date of first prescription of levodopa
- Individuals previously prescribed levodopa prior to study period
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 |
干预/治疗 |
|---|---|
|
New levodopa users
Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010 but no previous levodopa prescriptions prior to study period
|
levodopa use
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Occurrence of CV events during first 6 months
大体时间：0-6 months after first prescription of levodopa
|
0-6 months after first prescription of levodopa
|
|
Occurrence of CV events during second 6 months
大体时间：6-12 months after first prescription of levodopa
|
6-12 months after first prescription of levodopa
|
|
Occurrence of CV events during third 6 months
大体时间：12-18 months after first prescription of levodopa
|
12-18 months after first prescription of levodopa
|
|
Overall occurrence of CV events
大体时间：0-18 months overall after first prescription of levodopa
|
0-18 months overall after first prescription of levodopa
|
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。
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
2011年9月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2011年11月1日
研究注册日期
首次提交
2012年2月2日
首先提交符合 QC 标准的
2012年3月1日
首次发布 (估计)
2012年3月7日
研究记录更新
最后更新发布 (实际的)
2017年5月16日
上次提交的符合 QC 标准的更新
2017年5月15日
最后验证
2017年5月1日
更多信息
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.