ID

44243

Beschrijving

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

Trefwoorden

  1. 10-12-19 10-12-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Essential Hypertension NCT01146938

Eligibility Essential Hypertension NCT01146938

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
<hepatic impairment patient>
Beschrijving

Patient Hepatic impairment

Datatype

boolean

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
sex: male
Beschrijving

Gender

Datatype

boolean

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

Child-Pugh Classification

Datatype

boolean

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

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

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

Healthy Volunteers

Datatype

boolean

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
sex: male
Beschrijving

Gender

Datatype

boolean

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

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
<hepatic impairment patient>
Beschrijving

Patient Hepatic impairment

Datatype

boolean

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

Surgical Portosystemic Shunt

Datatype

boolean

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

Child-Pugh Classification

Datatype

boolean

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

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
ascites
Beschrijving

Ascites

Datatype

boolean

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

Healthy Volunteers

Datatype

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

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

Elevated total bilirubin

Datatype

boolean

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

Drug screen positive | Alcohol consumption screening Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2,1]
C0420032
UMLS CUI [2,2]
C1514241

Similar models

Eligibility Essential Hypertension NCT01146938

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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