Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
NCT01270711
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Adult Trials: 18+ Years
- 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
- 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).
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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. 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 | |||
| 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 |
| |||
| 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| 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 | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2014 | |||