ID
24790
Description
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease
Mots-clés
Versions (6)
- 17/08/2017 17/08/2017 -
- 17/08/2017 17/08/2017 -
- 28/08/2017 28/08/2017 -
- 01/09/2017 01/09/2017 -
- 04/09/2017 04/09/2017 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 août 2017
DOI
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Licence
Creative Commons BY-NC 3.0
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inclusion/exclusion criteria determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
inclusion/exclusion criteria determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Description
INCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
Description
adults without childbearing potential
Type de données
integer
Unités de mesure
- years
Alias
- UMLS CUI [1,1]
- C0001675
- UMLS CUI [1,2]
- C3831118
Description
diagnosis of Parkinson's disease according to Hoehn&Yahr Stage I-III
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0451215
Description
candidate and authorization for dopaminergic therapy
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0013036
- UMLS CUI [1,2]
- C0680281
Description
informed consent
Type de données
integer
Alias
- UMLS CUI [1]
- C0021430
Description
date informed consent signed:
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Description
investigator's signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
exception approved by medical monitor
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1705847
Description
name of medical monitor
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Description
date of approval
Type de données
date
Alias
- UMLS CUI [1]
- C2346844
Description
EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C0680251
Description
psychiatric, hematological, renal, hepatic, endocrinological, neurological or cardiovascular diseases or active malignancy
Type de données
integer
Alias
- UMLS CUI [1]
- C0004936
- UMLS CUI [2]
- C0018939
- UMLS CUI [3]
- C0022658
- UMLS CUI [4]
- C0023895
- UMLS CUI [5]
- C0014130
- UMLS CUI [6]
- C0027765
- UMLS CUI [7]
- C0007222
- UMLS CUI [8]
- C0006826
Description
AST or ALT or serum creatinine increased or other clinically significant laboratory or ECG abnormalities
Type de données
integer
Alias
- UMLS CUI [1]
- C0151904
- UMLS CUI [2]
- C0151905
- UMLS CUI [3]
- C0700225
- UMLS CUI [4]
- C0438215
- UMLS CUI [5]
- C1832603
Description
severe dizziness, syncope or orthostatic hypotension
Type de données
integer
Alias
- UMLS CUI [1]
- C0012833
- UMLS CUI [2]
- C0039070
- UMLS CUI [3]
- C0020651
Description
sleep disorder on Epworth sleep scale
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0851578
- UMLS CUI [1,2]
- C3541276
Description
L-dopa treatment
Type de données
integer
Alias
- UMLS CUI [1]
- C0023570
Description
dopaminergic therapy
Type de données
integer
Alias
- UMLS CUI [1]
- C0013036
Description
hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors
Type de données
integer
Alias
- UMLS CUI [1]
- C0282402
- UMLS CUI [2]
- C3850050
- UMLS CUI [3]
- C3850068
Description
hypersensitivity or adverse reactions to ropinirole
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2,1]
- C0559546
- UMLS CUI [2,2]
- C0244821
Description
investigational drugs
Type de données
integer
Alias
- UMLS CUI [1]
- C0013230
Description
drug abuse or abuse of alcohol
Type de données
integer
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Description
concern about the patient's compliance behavior and the use of new or prohibited concomitant medications
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [1,3]
- C2347852
Description
blood donation
Type de données
integer
Alias
- UMLS CUI [1]
- C0005794
Description
pregnancy or lactation
Type de données
integer
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Description
investigator's signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
exception approved by medical monitor
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1705847
Description
name of medical monitor
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Description
date of approval
Type de données
date
Alias
- UMLS CUI [1]
- C2346844
Similar models
inclusion/exclusion criteria determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
C3831118 (UMLS CUI [1,2])
C0451215 (UMLS CUI [1,2])
C0680281 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
C1832603 (UMLS CUI [5])
C0039070 (UMLS CUI [2])
C0020651 (UMLS CUI [3])
C3541276 (UMLS CUI [1,2])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
C0244821 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
C0085762 (UMLS CUI [2])
C0422727 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2])
C1705847 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])