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

An observational study of Parkinson's Disease and Hyperprolactinemia, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Parkinson's Disease, Hyperprolactinemia
What is being tested?: Study Drug
How many people: 22,014 participants
Where: No sites listed yet
Study dates: Nov 2010to Feb 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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).

About this study

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

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

Read the detailed description

does not involve random selection

Conditions: Parkinson's Disease, Hyperprolactinemia
Being tested: Study Drug
Keywords: compliance study, effectiveness study, hyperprolactinemia, Parkinson's disease, retrospective cohort study
Medical subject headings: Parkinson Disease, Hyperprolactinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study DrugDrug
non interventional study - usage as per usual care

Study groups in NCT01270711
Study group	Role	What they receive
Cabergoline users		cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012) Receives: Drug: Study Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Cabergoline Prescriptions by Database and Indication: Year 1
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Measured: Year 1 (Year 2006)
Number of Cabergoline Prescriptions by Database and Indication: Year 2
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Measured: Year 2 (Year 2007)
Number of Cabergoline Prescriptions by Database and Indication: Year 3
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Measured: Year 3 (Year 2008)
Number of Cabergoline Prescriptions by Database and Indication: Year 4
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Measured: Year 4 (Year 2009)
Number of Cabergoline Prescriptions by Database and Indication: Year 5
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Measured: Year 5 (Year 2010)
Number of Cabergoline Prescriptions by Database and Indication: Year 6
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Measured: Year 6 (Year 2011)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Measured: Year 1 (Year 2006)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Measured: Year 2 (Year 2007)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Measured: Year 3 (Year 2008)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Measured: Year 4 (Year 2009)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Measured: Year 5 (Year 2010)
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Measured: Year 6 (Year 2011)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Measured: Year 1 (Year 2006)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Measured: Year 2 (Year 2007)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Measured: Year 3 (Year 2008)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Measured: Year 4 (Year 2009)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Measured: Year 5 (Year 2010)
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Measured: Year 6 (Year 2011)
Total Number of Echocardiography Examinations in Cabergoline Users
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
Measured: Baseline (Week 1) up to Week 339
Incidence of Valvular Fibrosis
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
Measured: Baseline (Week 1) up to Week 339
Prevalence of Valvular Fibrosis
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.
Measured: Baseline (Week 1) up to Week 339

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Feb 2013

First posted5 Jan 2011 (estimated)
Study startNov 2010
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 22,014 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01270711
Sponsor's protocol ID: A7231030
Acronym: SUCRE
Status last verified: Feb 2014
First submitted: 9 Dec 2010
Last updated: 2 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
ClinicalTrials.gov ID: NCT01270711
Acronym / sponsor ID: SUCRE / A7231030
Conditions: Parkinson's Disease, Hyperprolactinemia
Keywords: compliance study, effectiveness study, hyperprolactinemia, Parkinson's disease, retrospective cohort study
Study type: Observational
Recruitment status: Completed
Enrolment: 22,014 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 5 Jan 2011 (estimated)
Results: Posted 24 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Cabergoline users	–	Drug: Study Drugcohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Study Drugnon interventional study - usage as per usual care	Drug	Cabergoline users

Primary outcome

Number of Cabergoline Prescriptions by Database and Indication: Year 1
Time frame: Year 1 (Year 2006)
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Number of Cabergoline Prescriptions by Database and Indication: Year 2
Time frame: Year 2 (Year 2007)
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Number of Cabergoline Prescriptions by Database and Indication: Year 3
Time frame: Year 3 (Year 2008)
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Number of Cabergoline Prescriptions by Database and Indication: Year 4
Time frame: Year 4 (Year 2009)
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Number of Cabergoline Prescriptions by Database and Indication: Year 5
Time frame: Year 5 (Year 2010)
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Number of Cabergoline Prescriptions by Database and Indication: Year 6
Time frame: Year 6 (Year 2011)
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
Time frame: Year 1 (Year 2006)
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
Time frame: Year 2 (Year 2007)
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
Time frame: Year 3 (Year 2008)
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
Time frame: Year 4 (Year 2009)
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
Time frame: Year 5 (Year 2010)
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
Time frame: Year 6 (Year 2011)
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
Time frame: Year 1 (Year 2006)
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
Time frame: Year 2 (Year 2007)
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
Time frame: Year 3 (Year 2008)
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
Time frame: Year 4 (Year 2009)
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
Time frame: Year 5 (Year 2010)
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
Time frame: Year 6 (Year 2011)
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Total Number of Echocardiography Examinations in Cabergoline Users
Time frame: Baseline (Week 1) up to Week 339
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
Incidence of Valvular Fibrosis
Time frame: Baseline (Week 1) up to Week 339
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
Prevalence of Valvular Fibrosis
Time frame: Baseline (Week 1) up to Week 339
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.

Results and safety

Results posted to the registry on 24 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aarhus [Part 1]	7,537	7,537
HSD [Part 1]	6,580	6,580
IPCI [Part 1]	326	326
PHARMO [Part 1]	5,486	5,486
THIN [Part 1]	2,024	2,024
Cabergoline in Pre-SPC Change Period [Part 2]	0	0
Cabergoline in Post- SPC Change Period [Part 2]	0	0
Cabergoline in Cross-SPC Change Period [Part 2]	0	0

Primary outcome: Number of Cabergoline Prescriptions by Database and Indication: Year 1

Time frame: Year 1 (Year 2006). Number. Unit: prescriptions

Measure	Aarhus [Part 1] n = 81	HSD [Part 1] n = 854	IPCI [Part 1] n = 5	PHARMO [Part 1] n = 277	THIN [Part 1] n = 370
G02CB03	17	1782	6	293	198
N04BC06	87	1483	0	0	577

Population analysed: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Number of Cabergoline Prescriptions by Database and Indication: Year 2

Time frame: Year 2 (Year 2007). Number. Unit: prescriptions

Measure	Aarhus [Part 1] n = 1446	HSD [Part 1] n = 1475	IPCI [Part 1] n = 31	PHARMO [Part 1] n = 1231	THIN [Part 1] n = 756
G02CB03	1925	3616	64	2698	3537
N04BC06	741	2139	0	0	3325

Primary outcome: Number of Cabergoline Prescriptions by Database and Indication: Year 3

Time frame: Year 3 (Year 2008). Number. Unit: prescriptions

Measure	Aarhus [Part 1] n = 1469	HSD [Part 1] n = 1089	IPCI [Part 1] n = 59	PHARMO [Part 1] n = 1081	THIN [Part 1] n = 279
G02CB03	2098	3493	152	2621	3556
N04BC06	507	807	0	0	1656

Primary outcome: Number of Cabergoline Prescriptions by Database and Indication: Year 4

Time frame: Year 4 (Year 2009). Number. Unit: prescriptions

Measure	Aarhus [Part 1] n = 1539	HSD [Part 1] n = 1146	IPCI [Part 1] n = 87	PHARMO [Part 1] n = 1039	THIN [Part 1] n = 220
G02CB03	2260	3629	226	2684	3240
N04BC06	306	463	0	0	1119

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aarhus [Part 1]	0 of 0	0 of 0	Not reported
HSD [Part 1]	0 of 0	0 of 0	Not reported
IPCI [Part 1]	0 of 0	0 of 0	Not reported
PHARMO [Part 1]	0 of 0	0 of 0	Not reported
THIN [Part 1]	0 of 0	0 of 0	Not reported
Cabergoline in Pre-SPC Change Period [Part 2]	0 of 0	0 of 0	Not reported
Cabergoline in Post- SPC Change Period [Part 2]	0 of 0	0 of 0	Not reported
Cabergoline in Cross-SPC Change Period [Part 2]	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Results not reported for Year 2012 (Year 7) since several databases did not contribute data for Year 7 and amount of person-time of follow-up dropped in all databases. Designation of primary and secondary endpoints was based on study team's input.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease and Hyperprolactinemia, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Cabergoline Prescriptions by Database and Indication: Year 1 (time frame: Year 1 (Year 2006)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01270711.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2014.