Cardiovascular Events in Parkinson's Disease Patients

Parkinson Disease Clinical Trial

Official title:

Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545856
• Other study ID #: 116493
• Secondary ID: WEUKBRE5922
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: May 15, 2017
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Event
• Parkinson Disease

Intervention

Drug:
• levodopa
levodopa use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of CV events during first 6 months		0-6 months after first prescription of levodopa
Primary	Occurrence of CV events during second 6 months		6-12 months after first prescription of levodopa
Primary	Occurrence of CV events during third 6 months		12-18 months after first prescription of levodopa
Primary	Overall occurrence of CV events		0-18 months overall after first prescription of levodopa