ID

41436

Beschreibung

Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction; ODM derived from: https://clinicaltrials.gov/show/NCT01444872

Link

https://clinicaltrials.gov/show/NCT01444872

Stichworte

Versionen (3)
  1. 16.01.19 16.01.19 -
  2. 05.10.20 05.10.20 -
  3. 07.10.20 07.10.20 -
Rechteinhaber

see on clinicaltrials.gov

Hochgeladen am

7. Oktober 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure and Renal Dysfunction NCT01444872

Englisch

Eligibility Heart Failure and Renal Dysfunction NCT01444872

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
heart failure
Beschreibung

Heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
mild to moderate renal dysfunction
Beschreibung

mild/moderate renal dysfunction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C2945599
age 18- <75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
males and females (non-childbearing potential)
Beschreibung

Gender, Non-childbearing potential)

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the investigator based on medical history, physical examination or laboratory tests
Beschreibung

Condition affecting interpretation of safety, efficacy based on medical history, physical examination or laboratory tests

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C4086187
UMLS CUI [1,4]
C1113679
UMLS CUI [1,5]
C0262926
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C4086187
UMLS CUI [2,4]
C1113679
UMLS CUI [2,5]
C0031809
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C4086187
UMLS CUI [3,4]
C1113679
UMLS CUI [3,5]
C0022885
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C4086187
UMLS CUI [4,4]
C1280519
UMLS CUI [4,5]
C0262926
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C4086187
UMLS CUI [5,4]
C1280519
UMLS CUI [5,5]
C0031809
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C4086187
UMLS CUI [6,4]
C1280519
UMLS CUI [6,5]
C0022885
any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the investigator
Beschreibung

life threatening disease affecting interpretation of safety or evaluation of efficacy data

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C4086187
UMLS CUI [1,5]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0220825
UMLS CUI [2,5]
C1280519
allergy or clinically-significant intolerance to arbs or ace inhibitors
Beschreibung

Allergy, clinically-significant intolerance to ARBs or ACE inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0277585
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C0521942
UMLS CUI [3,2]
C0277585
UMLS CUI [3,3]
C2826293
UMLS CUI [4,1]
C0521942
UMLS CUI [4,2]
C0020517
clinical signs or symptoms of acute decompensated heart failure
Beschreibung

signs and symptoms of acute decompensated heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C0037088
pregnant or lactating
Beschreibung

pregnant or lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Heart Failure and Renal Dysfunction NCT01444872

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI [1])
mild/moderate renal dysfunction
Item
mild to moderate renal dysfunction
boolean
C3279454 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3279454 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
Age
Item
age 18- <75
boolean
C0001779 (UMLS CUI [1])
Gender, Non-childbearing potential)
Item
males and females (non-childbearing potential)
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Condition affecting interpretation of safety, efficacy based on medical history, physical examination or laboratory tests
Item
any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the investigator based on medical history, physical examination or laboratory tests
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C4086187 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,5])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C4086187 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0031809 (UMLS CUI [2,5])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C4086187 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C0022885 (UMLS CUI [3,5])
C0348080 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C4086187 (UMLS CUI [4,3])
C1280519 (UMLS CUI [4,4])
C0262926 (UMLS CUI [4,5])
C0348080 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C4086187 (UMLS CUI [5,3])
C1280519 (UMLS CUI [5,4])
C0031809 (UMLS CUI [5,5])
C0348080 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C4086187 (UMLS CUI [6,3])
C1280519 (UMLS CUI [6,4])
C0022885 (UMLS CUI [6,5])
life threatening disease affecting interpretation of safety or evaluation of efficacy data
Item
any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the investigator
boolean
C0012634 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C4086187 (UMLS CUI [1,4])
C1113679 (UMLS CUI [1,5])
C0012634 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0220825 (UMLS CUI [2,4])
C1280519 (UMLS CUI [2,5])
Allergy, clinically-significant intolerance to ARBs or ACE inhibitors
Item
allergy or clinically-significant intolerance to arbs or ace inhibitors
boolean
C0003015 (UMLS CUI [1,1])
C0277585 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0521942 (UMLS CUI [3,1])
C0277585 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
C0521942 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
signs and symptoms of acute decompensated heart failure
Item
clinical signs or symptoms of acute decompensated heart failure
boolean
C0581377 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
pregnant or lactating
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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