ID

44243

Description

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01146938

Link

https://clinicaltrials.gov/show/NCT01146938

Keywords

Versions (2)
  1. 12/10/19 12/10/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Essential Hypertension NCT01146938

English

Eligibility Essential Hypertension NCT01146938

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
<hepatic impairment patient>
Description

Patient Hepatic impairment

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0948807
age: 20 - 64 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sex: male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
child-pugh score a or child-pugh score b
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
body weight: greater than 55 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
<healthy volunteer>
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
age: 20 - 64 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sex: male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
body weight: greater than 55 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
<hepatic impairment patient>
Description

Patient Hepatic impairment

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0948807
portosystemic shunt surgery
Description

Surgical Portosystemic Shunt

Data type

boolean

Alias
UMLS CUI [1]
C0032720
child-pugh score c
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
creatinine clearance < 80ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
ascites
Description

Ascites

Data type

boolean

Alias
UMLS CUI [1]
C0003962
<healthy volunteer>
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
ast(sgot), alt(sgpt) > 1.5 times of upper normal range
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
total bilirubin > 1.5 times of upper normal range
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
positive drug or alcohol screening
Description

Drug screen positive | Alcohol consumption screening Positive

Data type

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2,1]
C0420032
UMLS CUI [2,2]
C1514241
Back to the top of the page

Similar models

Eligibility Essential Hypertension NCT01146938

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient Hepatic impairment
Item
<hepatic impairment patient>
boolean
C0030705 (UMLS CUI [1,1])
C0948807 (UMLS CUI [1,2])
Age
Item
age: 20 - 64 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
sex: male
boolean
C0079399 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh score a or child-pugh score b
boolean
C4050412 (UMLS CUI [1])
Body Weight
Item
body weight: greater than 55 kg
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers
Item
<healthy volunteer>
boolean
C1708335 (UMLS CUI [1])
Age
Item
age: 20 - 64 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
sex: male
boolean
C0079399 (UMLS CUI [1])
Body Weight
Item
body weight: greater than 55 kg
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient Hepatic impairment
Item
<hepatic impairment patient>
boolean
C0030705 (UMLS CUI [1,1])
C0948807 (UMLS CUI [1,2])
Surgical Portosystemic Shunt
Item
portosystemic shunt surgery
boolean
C0032720 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh score c
boolean
C4050412 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance < 80ml/min
boolean
C0373595 (UMLS CUI [1])
Ascites
Item
ascites
boolean
C0003962 (UMLS CUI [1])
Healthy Volunteers
Item
<healthy volunteer>
boolean
C1708335 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast(sgot), alt(sgpt) > 1.5 times of upper normal range
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Elevated total bilirubin
Item
total bilirubin > 1.5 times of upper normal range
boolean
C0741494 (UMLS CUI [1])
Drug screen positive | Alcohol consumption screening Positive
Item
positive drug or alcohol screening
boolean
C0743295 (UMLS CUI [1])
C0420032 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial