ID

43843

Beskrivning

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00479401

Länk

https://clinicaltrials.gov/show/NCT00479401

Nyckelord

Versioner (2)
  1. 2017-07-26 2017-07-26 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Early Parkinson Disease (Early PD) NCT00479401

Engelsk

Eligibility Early Parkinson Disease (Early PD) NCT00479401

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patient with idiopathic parkinsons disease (pd) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Beskrivning

Gender | Parkinson Disease | Resting Tremor | Bradykinesia | Muscle Rigidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0234379
UMLS CUI [4]
C0233565
UMLS CUI [5]
C0026837
2. parkinsons disease diagnosed within 5 years.
Beskrivning

Parkinson Disease Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0872146
3. patients 30 years of age or older at the time of diagnosis.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. modified hoehn and yahr stage of 1 to 3.
Beskrivning

UPDRS - Modified Hoehn and Yahr Staging

Datatyp

boolean

Alias
UMLS CUI [1]
C3639878
5. patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, v1) according to the investigators judgement.
Beskrivning

Additional Therapy Parkinsonian symptoms | Introduction Therapeutic procedure Parkinsonian symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C0242422
UMLS CUI [2,1]
C0579004
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0242422
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
Beskrivning

Parkinsonian Disorders Atypical Due to Pharmaceutical Preparations | Metoclopramide | Flunarizine | Metabolic Diseases | Hepatolenticular Degeneration | Encephalitis | Degenerative disorder | Progressive supranuclear palsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0205182
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0013227
UMLS CUI [2]
C0025853
UMLS CUI [3]
C0016295
UMLS CUI [4]
C0025517
UMLS CUI [5]
C0019202
UMLS CUI [6]
C0014038
UMLS CUI [7]
C1285162
UMLS CUI [8]
C0038868
2. dementia, as defined by a mini-mental state exam score < 24 at screening visit
Beskrivning

Dementia Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
3. any psychiatric disorder according to diagnostic and statistical manual of mental disorders 4th (dsm-iv)
Beskrivning

Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
4. history of psychosis
Beskrivning

Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
5. clinically significant electrocardiogram (ecg) abnormalities at screening visit
Beskrivning

ECG abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
6. clinically significant hypotension
Beskrivning

Hypotension

Datatyp

boolean

Alias
UMLS CUI [1]
C0020649
7. malignant melanoma or history of previously treated malignant melanoma
Beskrivning

Melanoma | Prior Therapy Melanoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0025202
8. any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
Beskrivning

Disease At risk Patient | Disease Preventing Compliance | Disease Preventing Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2732579
9. pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
10. sexually active female of childbearing potential not using a medically approved method of birth control
Beskrivning

Gender Sexually active Contraceptive methods Lacking | Childbearing Potential Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332268
11. serum levels of aspartate aminotransferase (ast) , alanine aminotransferase (alt), alkaline phosphatases or bilirubin > 2 upper limit of normal (uln)
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151849
UMLS CUI [4]
C0741494
12. patients with a creatinine clearance < 50 ml/min
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
13. any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or l-dopa within 8 weeks prior to baseline visit.
Beskrivning

Dopamine Agonists | Pramipexole | Levodopa

Datatyp

boolean

Alias
UMLS CUI [1]
C0178601
UMLS CUI [2]
C0074710
UMLS CUI [3]
C0023570
14. total cumulative duration of prior exposure to levodopa of more than 3 months.
Beskrivning

Levodopa Exposure to | Duration Cumulative Total

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C0449238
UMLS CUI [2,2]
C1511559
UMLS CUI [2,3]
C0439810
15. any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
Beskrivning

Dopamine Antagonists | Dopamine Antagonists Formulation Intramuscular

Datatyp

boolean

Alias
UMLS CUI [1]
C0242702
UMLS CUI [2,1]
C0242702
UMLS CUI [2,2]
C0524527
UMLS CUI [2,3]
C0442117
16. any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
Beskrivning

Methylphenidate | Cinnarizine | Amphetamines

Datatyp

boolean

Alias
UMLS CUI [1]
C0025810
UMLS CUI [2]
C0008803
UMLS CUI [3]
C0002667
17. flunarizine within 3 months prior to baseline visit
Beskrivning

Flunarizine

Datatyp

boolean

Alias
UMLS CUI [1]
C0016295
18. known hypersensitivity to pramipexole or its excipients
Beskrivning

Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074710
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0074710
UMLS CUI [2,3]
C0015237
19. drug abuse (including alcohol), according to investigators judgement, within 2 years prior to screening.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
20. participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Early Parkinson Disease (Early PD) NCT00479401

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Parkinson Disease | Resting Tremor | Bradykinesia | Muscle Rigidity
Item
1. male or female patient with idiopathic parkinsons disease (pd) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0234379 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
Parkinson Disease Disease length
Item
2. parkinsons disease diagnosed within 5 years.
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
3. patients 30 years of age or older at the time of diagnosis.
boolean
C0001779 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
4. modified hoehn and yahr stage of 1 to 3.
boolean
C3639878 (UMLS CUI [1])
Additional Therapy Parkinsonian symptoms | Introduction Therapeutic procedure Parkinsonian symptoms
Item
5. patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, v1) according to the investigators judgement.
boolean
C1706712 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
C0579004 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0242422 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Parkinsonian Disorders Atypical Due to Pharmaceutical Preparations | Metoclopramide | Flunarizine | Metabolic Diseases | Hepatolenticular Degeneration | Encephalitis | Degenerative disorder | Progressive supranuclear palsy
Item
1. atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
boolean
C0242422 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0025853 (UMLS CUI [2])
C0016295 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
C0019202 (UMLS CUI [5])
C0014038 (UMLS CUI [6])
C1285162 (UMLS CUI [7])
C0038868 (UMLS CUI [8])
Dementia Mini-mental state examination
Item
2. dementia, as defined by a mini-mental state exam score < 24 at screening visit
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Mental disorders
Item
3. any psychiatric disorder according to diagnostic and statistical manual of mental disorders 4th (dsm-iv)
boolean
C0004936 (UMLS CUI [1])
Psychotic Disorders
Item
4. history of psychosis
boolean
C0033975 (UMLS CUI [1])
ECG abnormality
Item
5. clinically significant electrocardiogram (ecg) abnormalities at screening visit
boolean
C0522055 (UMLS CUI [1])
Hypotension
Item
6. clinically significant hypotension
boolean
C0020649 (UMLS CUI [1])
Melanoma | Prior Therapy Melanoma
Item
7. malignant melanoma or history of previously treated malignant melanoma
boolean
C0025202 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0025202 (UMLS CUI [2,2])
Disease At risk Patient | Disease Preventing Compliance | Disease Preventing Completion of clinical trial
Item
8. any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Pregnancy
Item
9. pregnancy
boolean
C0032961 (UMLS CUI [1])
Gender Sexually active Contraceptive methods Lacking | Childbearing Potential Contraceptive methods Lacking
Item
10. sexually active female of childbearing potential not using a medically approved method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin
Item
11. serum levels of aspartate aminotransferase (ast) , alanine aminotransferase (alt), alkaline phosphatases or bilirubin > 2 upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Creatinine clearance measurement
Item
12. patients with a creatinine clearance < 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Dopamine Agonists | Pramipexole | Levodopa
Item
13. any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or l-dopa within 8 weeks prior to baseline visit.
boolean
C0178601 (UMLS CUI [1])
C0074710 (UMLS CUI [2])
C0023570 (UMLS CUI [3])
Levodopa Exposure to | Duration Cumulative Total
Item
14. total cumulative duration of prior exposure to levodopa of more than 3 months.
boolean
C0023570 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2,1])
C1511559 (UMLS CUI [2,2])
C0439810 (UMLS CUI [2,3])
Dopamine Antagonists | Dopamine Antagonists Formulation Intramuscular
Item
15. any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
boolean
C0242702 (UMLS CUI [1])
C0242702 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0442117 (UMLS CUI [2,3])
Methylphenidate | Cinnarizine | Amphetamines
Item
16. any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
boolean
C0025810 (UMLS CUI [1])
C0008803 (UMLS CUI [2])
C0002667 (UMLS CUI [3])
Flunarizine
Item
17. flunarizine within 3 months prior to baseline visit
boolean
C0016295 (UMLS CUI [1])
Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient
Item
18. known hypersensitivity to pramipexole or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0074710 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0074710 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Substance Use Disorders
Item
19. drug abuse (including alcohol), according to investigators judgement, within 2 years prior to screening.
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
20. participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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