ID

41436

Description

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

Keywords

Versions (3)
  1. 1/16/19 1/16/19 -
  2. 10/5/20 10/5/20 -
  3. 10/7/20 10/7/20 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

October 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure and Renal Dysfunction NCT01444872

English

Eligibility Heart Failure and Renal Dysfunction NCT01444872

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
heart failure
Description

Heart failure

Data type

boolean

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

mild/moderate renal dysfunction

Data type

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
Description

Age

Data type

boolean

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

Gender, Non-childbearing potential)

Data type

boolean

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

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
Description

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

Data type

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
Description

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

Data type

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
Description

Allergy, clinically-significant intolerance to ARBs or ACE inhibitors

Data type

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
Description

signs and symptoms of acute decompensated heart failure

Data type

boolean

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

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Heart Failure and Renal Dysfunction NCT01444872

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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