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OpenTrials
Completed

NCT Number: NCT01545856

Cardiovascular Events in Parkinson's Disease Patients

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.

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Key information

Conditions

Cardiovascular Event Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levodopa

Drug

levodopa use

Primary outcomes

  1. Occurrence of CV events during first 6 months

    Time frame: 0-6 months after first prescription of levodopa

  2. Occurrence of CV events during second 6 months

    Time frame: 6-12 months after first prescription of levodopa

  3. Occurrence of CV events during third 6 months

    Time frame: 12-18 months after first prescription of levodopa

  4. Overall occurrence of CV events

    Time frame: 0-18 months overall after first prescription of levodopa

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 7, 2012
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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