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

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NCT01270711

Last updated on October 11, 2019

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About this Study

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

Study Location

Contact

1-800-718-1021

[email protected]

Eligibility criteria

Condition

Parkinson's Disease, Hyperprolactinemia

Sex

Females and Males

Age

0 +

Inclusion criteria

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

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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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information

Brief Title

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

Official Title

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

Brief Summary

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

Detailed Description

does not involve random selection

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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.

Condition

Parkinson's Disease
Hyperprolactinemia

Intervention

Drug: Study Drug

non interventional study - usage as per usual care

Study Groups/Cohorts

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Actual Enrollment

22014

Original Estimated Enrollment

10000

Actual Study Completion Date

February 2013

Actual Primary Completion Date

February 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Older Adult

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Not Provided

Removed Location Countries

Administrative Information

NCT Number

NCT01270711

Other Study ID Numbers

A7231030

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Pfizer

Study Sponsor

Pfizer

Collaborators

Not Provided

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

February 2014

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

NCT01270711

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

NCT01270711

About this Study

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