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
  Purpose

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.


Condition Intervention
Cardiovascular Event
Parkinson Disease
Drug: levodopa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: levodopa
levodopa use

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545856

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01545856     History of Changes
Other Study ID Numbers: 116493, WEUKBRE5922
Study First Received: February 2, 2012
Last Updated: March 1, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Parkinson's Disease
cardiovascular events
Levodopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014