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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease; Hyperprolactinemia

Intervention: Study Drug (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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. 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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Number of Cabergoline Prescriptions by Database and Indication: Year 1

Number of Cabergoline Prescriptions by Database and Indication: Year 2

Number of Cabergoline Prescriptions by Database and Indication: Year 3

Number of Cabergoline Prescriptions by Database and Indication: Year 4

Number of Cabergoline Prescriptions by Database and Indication: Year 5

Number of Cabergoline Prescriptions by Database and Indication: Year 6

Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1

Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2

Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3

Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4

Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5

Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6

Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1

Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2

Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3

Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4

Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5

Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6

Total Number of Echocardiography Examinations in Cabergoline Users

Incidence of Valvular Fibrosis

Prevalence of Valvular Fibrosis

Detailed description: does not involve random selection

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2010
Last updated: April 14, 2014

Page last updated: August 23, 2015

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