Cardiovascular Events in Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01545856
First received: February 2, 2012
Last updated: March 1, 2012
Last verified: February 2012

February 2, 2012
March 1, 2012
September 2011
November 2011   (final data collection date for primary outcome measure)
  • Occurrence of CV events during first 6 months [ Time Frame: 0-6 months after first prescription of levodopa ] [ Designated as safety issue: Yes ]
  • Occurrence of CV events during second 6 months [ Time Frame: 6-12 months after first prescription of levodopa ] [ Designated as safety issue: Yes ]
  • Occurrence of CV events during third 6 months [ Time Frame: 12-18 months after first prescription of levodopa ] [ Designated as safety issue: Yes ]
  • Overall occurrence of CV events [ Time Frame: 0-18 months overall after first prescription of levodopa ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01545856 on ClinicalTrials.gov Archive Site
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Cardiovascular Events in Parkinson's Disease Patients
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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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.

  • Cardiovascular Event
  • Parkinson Disease
Drug: levodopa
levodopa use
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
Intervention: Drug: levodopa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01545856
116493, WEUKBRE5922
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP