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Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)

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

- Treated with cabergoline during the study period (January 1st, 2006 and will end on
July 1st 2012) and identified in one of 6 databases: The Health Information Network,
Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus
hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention

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

- Patients with eligibility dates that start after July 1st 2007 (meaning that they
would have less than one year of valid data before publication of the results of the
EMEA review), will be excluded as well as patients whose eligibility ends before July
1st 2008 (date of SmPC changes).

NCT01270711
Pfizer
Completed
Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)

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Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)

The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline.

Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis

does not involve random selection
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Cohort of patients, who are treated with cabergoline during the study period. This cohort will be divided in new users and prevalent users based on when cabergoline was started. New (incident) users will be all persons who have a first prescription for cabergoline after the date that the change in SPC was made. Prevalent users will be all cohort members who received a cabergoline prescription during the study period but who had also been using cabergoline prior to the change in SPC.
  • Parkinson's Disease
  • Hyperprolactinemia
Drug: Study Drug
non interventional study - usage as per usual care
Cabergoline users
cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)
Intervention: Drug: Study Drug
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22014
February 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated with cabergoline during the study period (January 1st, 2006 and will end on July 1st 2012) and identified in one of 6 databases: The Health Information Network, Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention

Exclusion Criteria:

  • Patients with eligibility dates that start after July 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the EMEA review), will be excluded as well as patients whose eligibility ends before July 1st 2008 (date of SmPC changes).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01270711
A7231030
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

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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1-800-718-1021

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[email protected]



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