Informações:
Falhas:
ID
42299
Descrição
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension
Palavras-chave
Versões (1)
- 12/05/2021 12/05/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
12 de maio de 2021
DOI
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Licença
Creative Commons BY 4.0
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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)
Similar models
Pharmacogenetics
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-3)
C2985720 (UMLS CUI-3)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item Group
PGx-Pharmacogenetic Research Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-3)
C0021430 (UMLS CUI-3)
Has informed consent been otained for PGx-Pharmacogenetic research?
Item
Has informed consent been otained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1])
C2347500 (UMLS CUI [2])
C2347500 (UMLS CUI [2])
Date informed consent obtained for PGx-Pharmacogenetic research
Item
Date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1])
C2347500 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C2347500 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Record Date sample taken
Item
Record Date sample taken
date
C1302413 (UMLS CUI [1])
Item
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason
integer
C0021430 (UMLS CUI [1])
C2347500 (UMLS CUI [2])
C0392360 (UMLS CUI [3])
C2347500 (UMLS CUI [2])
C0392360 (UMLS CUI [3])
Code List
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
If other reason for informed consent has not been obtained, specify
Item
If other reason for informed consent has not been obtained, specify
text
C0021430 (UMLS CUI [1])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-3)
C0031325 (UMLS CUI-3)
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C1272683 (UMLS CUI [3])
C0178913 (UMLS CUI [2])
C1272683 (UMLS CUI [3])
Item
If request for sample destruction has been made, check reason
integer
C1948029 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C1272683 (UMLS CUI [3])
C0392360 (UMLS CUI [4])
C0178913 (UMLS CUI [2])
C1272683 (UMLS CUI [3])
C0392360 (UMLS CUI [4])
Code List
If request for sample destruction has been made, check reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Specify other reason for sample destruction
Item
Specify other reason for sample destruction
text
C1948029 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C0392360 (UMLS CUI [3])
C0205394 (UMLS CUI [4,1])
C2348235 (UMLS CUI [4,2])
C0178913 (UMLS CUI [2])
C0392360 (UMLS CUI [3])
C0205394 (UMLS CUI [4,1])
C2348235 (UMLS CUI [4,2])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])