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

Pfizer

Status: Completed

Conditions: Parkinson's Disease; Hyperprolactinemia

Treatments: Drug: Study Drug

Study type: Observational

Funder types: Industry

Identifiers

NCT01270711

A7231030

Details and patient eligibility

About

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

Full description

does not involve random selection

Enrollment: 22,014 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

22,014 participants in 1 patient group

Cabergoline users

Description:

cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)

Treatment:

Drug: Study Drug