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To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirapex | Active Comparator | Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines |
|
| Requip | Active Comparator | Requip tablets three times daily (TID) dosing according to manufacturer's guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirapex | Drug | Standard marketed product dispensed according to manufacturer's guidelines |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Expert Panel Overall Assessment Following 2 Years on Drug | Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Expert Panel Overall Assessment Following 1 Year on Drug | Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments | up to 1 years |
| Hoehn and Yahr Scale at Baseline |
Not provided
Inclusion criteria
Diagnosis and main criteria for inclusion. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion criteria
Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 248.538.00007 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| 248.538.00008 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28078162 | Derived | Seiple W, Jennings D, Rosen RB, Borchert L, Canale L, Fagan N, Gordon MF. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease. Parkinsons Dis. 2016;2016:8298503. doi: 10.1155/2016/8298503. Epub 2016 Dec 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pramipexole | Flexible: 0.125 mg 3 times daily up to maximum tolerated |
| FG001 | Ropinirole | Flexible: 0.25 mg 3 times daily up to maximum tolerated |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Requip |
| Drug |
Standard marketed product dispensed according to manufacturer's guidelines |
|
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
| Baseline |
| Hoehn and Yahr Scale at 1 Year | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) | Up to 1 year |
| Hoehn and Yahr Scale at 2 Years | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) | Up to 2 years |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | Baseline |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | 1 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | Baseline, 1 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | 2 years |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | Baseline, 2 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | Baseline |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | 1 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | Baseline, 1 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | 2 years |
| Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | Baseline, 2 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | Baseline |
| Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | 1 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | Baseline, 1 year |
| Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | 2 years |
| Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | Baseline, 2 year |
| Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported. | Screen (Baseline) and final visit (24 months) |
| Little Rock |
| Arkansas |
| United States |
| 248.538.00021 Boehringer Ingelheim Investigational Site | Fountain Valley | California | United States |
| 248.538.00022 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States |
| 248.538.00001 Boehringer Ingelheim Investigational Site | New Haven | Connecticut | United States |
| 248.538.00002 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 248.538.00016 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 248.538.00023 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 248.538.00013 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 248.538.00009 Boehringer Ingelheim Investigational Site | Augusta | Georgia | United States |
| 248.538.00011 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 248.538.00005 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 248.538.00014 Boehringer Ingelheim Investigational Site | Southfield | Michigan | United States |
| 248.538.00010 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 248.538.00015 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 248.538.00020 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 248.538.00012 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States |
| 248.538.00006 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 248.538.00004 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | United States |
| 248.538.00003 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 248.538.00017 Boehringer Ingelheim Investigational Site | Morgantown | West Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pramipexole | Flexible: 0.125 mg 3 times daily up to maximum tolerated |
| BG001 | Ropinirole | Flexible: 0.25 mg 3 times daily up to maximum tolerated |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Height | Measurements collected for 120, 125 participants in Pramipexole, Ropinirole respectively | Mean | Standard Deviation | centimeters |
| ||||||||||||||
| Weight | Measurements collected for 119, 122 participants in Pramipexole, Ropinirole respectively | Mean | Standard Deviation | kilograms |
| ||||||||||||||
| Duration of Parkinson's disease diagnosis | Mean | Standard Deviation | years |
| |||||||||||||||
| Hoehn and Yahr stage | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) | Number | Participants |
| |||||||||||||||
| Alcohol history | Number | Participants |
|
| 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 | Expert Panel Overall Assessment Following 2 Years on Drug | Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments | FAS LOCF - full analysis set with last observation carry forward | Posted | Number | Participants | up to 2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Expert Panel Overall Assessment Following 1 Year on Drug | Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments | FAS LOCF - full analysis set with last observation carry forward | Posted | Number | Participants | up to 1 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hoehn and Yahr Scale at Baseline | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) | TS - treated set | Posted | Number | Participants | Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hoehn and Yahr Scale at 1 Year | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) | TS - treated set | Posted | Number | Participants | Up to 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hoehn and Yahr Scale at 2 Years | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) | TS - treated set | Posted | Number | Participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years | Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 2 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years | Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 2 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years | This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). | TS - treated set | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 2 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported. | TSlab - treated set with non-missing laboratory evaluations | Posted | Number | participants | Screen (Baseline) and final visit (24 months) |
|
|
up to 24 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pramipexole | Flexible: 0.125 mg 3 times daily up to maximum tolerated | 22 | 121 | 97 | 121 | ||
| EG001 | Ropinirole | Flexible: 0.25 mg 3 times daily up to maximum tolerated | 21 | 125 | 101 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Ovarian granulosa-theca cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hyperthecosis | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Sudden onset of sleep | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
|
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| C046649 | ropinirole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| 50 to < 65 years |
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| 65 to < 75 years |
|
| >= 75 years |
|
| Male |
|
| Black |
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| White |
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| Stage 1 |
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| Stage 1.5 |
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| Stage 2 |
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| Stage 2.5 |
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| Stage 3 |
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| Stage 4 |
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| Stage 5 |
|
| Has an average consumption |
|
| Fulfills criteria for Abuse/Dependence |
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