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
Finalized
Finalized
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:
Drug: levodopa
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
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
Finalized
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
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