ID

29239

Description

Effect of Renal Impairment on the Pharmacokinetics of NN9535; ODM derived from: https://clinicaltrials.gov/show/NCT00833716

Link

https://clinicaltrials.gov/show/NCT00833716

Keywords

Versions (1)
  1. 3/10/18 3/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00833716

English

Eligibility Diabetes NCT00833716

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00833716
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft & gault formula) for any of the renal function groups
Description

Glomerular Filtration Rate | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2]
C2711451
body mass index (bmi) equal to or less than 40kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product(s) or related products
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
renal transplanted patients
Description

Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0022671
certain cardiac problems (heart failure, unstable angina, mi (myocardial infarction) within the last 3 months)
Description

Cardiac problem | Heart failure | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0262402
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
known current hepatic dysfunction or severe hepatic disease during the last 12 months
Description

Liver Dysfunction | Liver disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
female of childbearing potential/breast feeding
Description

Childbearing Potential | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0006147
history of alcoholism or drug abuse
Description

Alcoholic Intoxication, Chronic | Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
blood donation during the last 8 weeks prior to the study
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
past or current history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
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Similar models

Eligibility Diabetes NCT00833716

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00833716
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
Glomerular Filtration Rate | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft & gault formula) for any of the renal function groups
boolean
C0017654 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) equal to or less than 40kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Kidney Transplantation
Item
renal transplanted patients
boolean
C0022671 (UMLS CUI [1])
Cardiac problem | Heart failure | Angina, Unstable | Myocardial Infarction
Item
certain cardiac problems (heart failure, unstable angina, mi (myocardial infarction) within the last 3 months)
boolean
C0262402 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Liver Dysfunction | Liver disease Severe
Item
known current hepatic dysfunction or severe hepatic disease during the last 12 months
boolean
C0086565 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Childbearing Potential | Breast Feeding
Item
female of childbearing potential/breast feeding
boolean
C3831118 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Drug abuse
Item
history of alcoholism or drug abuse
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Blood Donation
Item
blood donation during the last 8 weeks prior to the study
boolean
C0005794 (UMLS CUI [1])
Pancreatitis
Item
past or current history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
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