ID

25057

Descrição

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: PGx-Pharamacogenetic research.

Palavras-chave

Versões (2)
  1. 25/08/2017 25/08/2017 -
  2. 08/09/2017 08/09/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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PGx-Pharamacogenetic research GSK study Dyskinesia in Parkinson's disease NCT00363727

Inglês

PGx-Pharamacogenetic research study Dyskinesia in Parkinson's disease NCT00363727

1 Formulários  
General information
Descrição

General information

Protocol identifier
Descrição

Protocol identifier

Tipo de dados

text

Subject identifier
Descrição

Subject identifier

Tipo de dados

text

Consent for PGx-Pharamacogenetic research
Descrição

Consent for PGx-Pharamacogenetic research

Has informed consent been obtained for PGx-Pharmacogenetic research?
Descrição

The question "Has informed consent been obtained for PGx-Pharmacogenetic research?" should be completed at either Visit 6, Early Withdrawal, or Follow-Up Visit. If the question is answered No, check one box for reason and do not complete the remainder of the page.

Tipo de dados

boolean

If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Descrição

date consent PGx-Pharmacogenetic research

Tipo de dados

date

If No, check one reason:
Descrição

reason consent unavailable

Tipo de dados

text

If other reason, specify
Descrição

reason consent unavailable specification

Tipo de dados

text

Blood sample collection (DNA)
Descrição

Blood sample collection (DNA)

Has a blood sample been collected for PGx-pharmacogenetic research?
Descrição

Blood sample collection

Tipo de dados

boolean

If Yes, record the date sample taken
Descrição

Blood sample collection date

Tipo de dados

date

Withdrawal of consent
Descrição

Withdrawal of consent

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Descrição

The question "Has the subject withdrawn consent for PGx-Pharmacogenetic research?" must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section below completed.

Tipo de dados

boolean

Blood sample destruction
Descrição

Blood sample destruction

Has a request been made for sample destruction?
Descrição

Do not complete this section if a blood sample was not collected. The question "Has a request been made for sample destruction?" must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research.

Tipo de dados

boolean

If Yes, check one reason:
Descrição

Blood sample destruction reason

Tipo de dados

text

If other reason, specify
Descrição

Blood sample destruction reason specification

Tipo de dados

text

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Similar models

PGx-Pharamacogenetic research study Dyskinesia in Parkinson's disease NCT00363727

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
text
Subject identifier
Item
Subject identifier
text
Item Group
Consent for PGx-Pharamacogenetic research
Consent for PGx-pharmagogenetic research
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
date consent PGx-Pharmacogenetic research
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
Item
If No, check one reason:
text
reason consent unavailable
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (Z)
Item
If other reason, specify
text
reason consent unavailable
Code List
If other reason, specify
Item Group
Blood sample collection (DNA)
Blood sample collection
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
Blood sample collection date
Item
If Yes, record the date sample taken
date
Item Group
Withdrawal of consent
Withdrawal of consent
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
Item Group
Blood sample destruction
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
Item
If Yes, check one reason:
text
Blood sample destruction reason
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Blood sample destruction reason specification
Item
If other reason, specify
text
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