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

Learn more about:
Related Clinical Trial
Administration of Kisspeptin to Subjects With Reproductive Disorders The Luveris In Vitro Fertilization Trial A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders Pituitary Function and Spontaneous Intracranial Hypotension Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility Aripiprazole and Prolactin Study Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia Characterization of Macroprolactinemia Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) Endometriosis Patients Undergoing Quinagolide Treatment Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine Peony-Glycyrrhiza Decoction (PGD) for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire Hyperprolactinemia and Adrenal Steroidogenesis Administration of Kisspeptin in Patients With Hyperprolactinemia Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

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


Primary Outcome

Number of Cabergoline Prescriptions by Database and Indication: Year 1


Condition

Parkinson's Disease

Intervention

Study Drug

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

22014

Start Date

November 2010

Completion Date

February 2013

Primary Completion Date

February 2013

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).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, , 



Administrative Informations


NCT ID

NCT01270711

Organization ID

A7231030


Responsible Party

Sponsor

Study Sponsor

Pfizer


Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer


Verification Date

February 2014