Last updated: 11/03/2018 19:13:39
Cardiovascular events in Parkinson's disease patients
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Background incidence of cardiovascular ischaemic events in treated Parkinson's disease patients in the Impact database
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of CV events during first 6 months
Timeframe: 0-6 months after first prescription of levodopa
Occurrence of CV events during second 6 months
Timeframe: 6-12 months after first prescription of levodopa
Occurrence of CV events during third 6 months
Timeframe: 12-18 months after first prescription of levodopa
Overall occurrence of CV events
Timeframe: 0-18 months overall after first prescription of levodopa
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
cardiovascular event, Parkinson Disease
Product
levodopa
Collaborators
Not applicable
Study date(s)
September 2011 to September 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- 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 less than 20 years of age on date of first prescription of levodopa
- Individuals previously prescribed levodopa prior to study period
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-16-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website