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The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson's Disease, Hyperprolactinemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- At least one year registered with the general practitioner (GP), one year of valid
data from the GP, or the date of software conversion (if GP software systems had
changed) and meeting criteria for any one of the 4 cohorts as defined.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- rheumatic heart disease

- congenital heart disease: includes structural defects, congenital arrhythmias, and
cardiomyopathies

- dilated cardiomyopathy (congestive cardiomyopathy

- pericardial, pleural, pulmonary or retroperitoneal fibrosis

- endocarditis or myocarditis

- carcinoid syndrome

- intravenous drug abuse

- fibrotic valvular heart disease

- pleural/pulmonary/pericardial/retroperitoneal fibroses

- use of fenfluramine or amiodarone within 3 years prior to date of diagnosis of
fibrotic valvular heart disease

NCT01052948
Pfizer
Completed
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

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The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:

  1. Cardiac valve regurgitation
  2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
  3. Heart failure
  4. Total, cardiac and respiratory mortality
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
General research practice databases or record linkage systems in Europe that provide access to original medical information. These are: The Health Information Network (THIN), Health Search Database (HSD)-THALES, the Integrated Primary Care Information (IPCI) and PHARMO-Record Linkage System (RLS) and meeting criteria for entry into any of the 4 cohorts between 1995 - 2007
  • Parkinson's Disease
  • Hyperprolactinemia
Other: Retrospective study-
  • Cohort 1
    All persons who newly start one of the dopamine agonists (DA) after start of eligibility period
    Intervention: Other: Retrospective study-
  • Cohort 2
    All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.
    Intervention: Other: Retrospective study-
  • Cohort 3
    All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.
    Intervention: Other: Retrospective study-
  • Cohort 4
    healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists
    Intervention: Other: Retrospective study-
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86939
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least one year registered with the general practitioner (GP), one year of valid data from the GP, or the date of software conversion (if GP software systems had changed) and meeting criteria for any one of the 4 cohorts as defined.

Exclusion Criteria:

  • rheumatic heart disease
  • congenital heart disease: includes structural defects, congenital arrhythmias, and cardiomyopathies
  • dilated cardiomyopathy (congestive cardiomyopathy
  • pericardial, pleural, pulmonary or retroperitoneal fibrosis
  • endocarditis or myocarditis
  • carcinoid syndrome
  • intravenous drug abuse
  • fibrotic valvular heart disease
  • pleural/pulmonary/pericardial/retroperitoneal fibroses
  • use of fenfluramine or amiodarone within 3 years prior to date of diagnosis of fibrotic valvular heart disease
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01052948
A7231031
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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