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To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | All persons who newly start one of the dopamine agonists (DA) after start of eligibility period |
| |
| Cohort 2 | All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior. |
| |
| Cohort 3 | All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior. |
| |
| Cohort 4 | healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrospective study- | Other |
| ||
| Retrospective study- |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up | Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds. | Up to 12 years |
| Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up | Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis | Up to 12 years |
| Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up | Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale | Up to 12 years |
| Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up | All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory. | Up to 12 years |
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Inclusion Criteria:
Exclusion Criteria:
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General research practice databases or record linkage systems in Europe that provide access to original medical information. These are: The Health Information Network (THIN), Health Search Database (HSD)-THALES, the Integrated Primary Care Information (IPCI) and PHARMO-Record Linkage System (RLS) and meeting criteria for entry into any of the 4 cohorts between 1995 - 2007
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Noninterventional retrospective cohort study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dopamine Agonist (Cohort 1) | Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine. |
| FG001 | Levodopa (Cohort 2) | Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior. |
| FG002 | Hyperprolactinemia (Cohort 3) | Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior. |
| FG003 | Healthy Controls (Cohort 4) | Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dopamine Agonist (Cohort 1) | Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up | Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds. | Per protocol. | Posted | Number | Participants/10,000 Participant-Years | Up to 12 years |
|
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Information about adverse events was not collected during this observational, noninterventional, case control study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dopamine Agonist (Cohort 1) | Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006966 | Hyperprolactinemia |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012189 | Retrospective Studies |
| ID | Term |
|---|---|
| D016022 | Case-Control Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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|
| Retrospective study- | Other |
|
| Retrospective study- | Other |
|
| BG001 | Levodopa (Cohort 2) | Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior. |
| BG002 | Hyperprolactinemia (Cohort 3) | Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior. |
| BG003 | Healthy Controls (Cohort 4) | Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Levodopa (Cohort 2) | Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior. |
| OG002 | Hyperprolactinemia (Cohort 3) | Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior. |
| OG003 | Healthy Controls (Cohort 4) | Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA. |
|
|
| Primary | Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up | Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis | Per protocol. | Posted | Number | Participants/10,000 Participant-Years | Up to 12 years |
|
|
|
| Primary | Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up | Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale | Per protocol. | Posted | Number | Participants/10,000 Participant-Years | Up to 12 years |
|
|
|
| Primary | Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up | All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory. | Per protocol. | Posted | Number | Participants/10,000 Participant-Years | Up to 12 years |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Levodopa (Cohort 2) | Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior. | 0 | 0 | 0 | 0 |
| EG002 | Hyperprolactinemia (Cohort 3) | Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior. | 0 | 0 | 0 | 0 |
| EG003 | Healthy Controls (Cohort 4) | Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA. | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008919 | Investigative Techniques |
| D015331 | Cohort Studies |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |