ID

31806

Descripción

A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.; ODM derived from: https://clinicaltrials.gov/show/NCT00938158

Link

https://clinicaltrials.gov/show/NCT00938158

Palabras clave

Versiones (1)
  1. 29/9/18 29/9/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de septiembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Renal Impairment NCT00938158

Inglés

Eligibility Renal Impairment NCT00938158

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
normal renal function or renal impairment
Descripción

Renal function | Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C1565489
stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200ml/min (cohort 3 only)
Descripción

Hemodialysis Stable | Hemodialysis Hour Quantity Blood Flow Rate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0439227
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1999075
neither pregnant nor lactating
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
hba1c 6-10.5% inclusive
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
females of childbearing potential must be practicing adequate contraception.
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to meet the pk objectives of the study
Descripción

PK Objectives Fulfill Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0018017
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C1299582
history of hypoglycemia unawareness or severe hypoglycemia
Descripción

Loss of hypoglycemic warning | Hypoglycemia Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
liver function tests greater than or equal to 2 times the uln
Descripción

Increased liver function tests

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877359
clinically significant cardiovascular and/or cerebrovascular disease
Descripción

Cardiovascular Diseases | Cerebrovascular Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
positive test results for hepatitis b, hepatitis c, or hiv
Descripción

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
documented hypertension or hypotension at screening
Descripción

Hypertensive disease | Hypotension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0020649
known hepatic or biliary abnormalities
Descripción

Abnormality of the liver | Biliary tract abnormality

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4021780
UMLS CUI [2]
C0549613
current use of sulfonylureas
Descripción

Sulfonylureas

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038766
active history of tobacco use within 6 months before screening
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
donation of blood in excess of 500ml within 56 days before albiglutide dosing
Descripción

Blood Donation Excess | Status pre- Albiglutide Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1979886
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C2607479
UMLS CUI [2,3]
C0178602
receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
previous or current receipt of exenatide or any other glp-1 agonist
Descripción

Exenatide | GLP-1 Receptor Agonist

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C2917359
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Similar models

Eligibility Renal Impairment NCT00938158

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Renal function | Renal Insufficiency
Item
normal renal function or renal impairment
boolean
C0232804 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Hemodialysis Stable | Hemodialysis Hour Quantity Blood Flow Rate
Item
stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200ml/min (cohort 3 only)
boolean
C0019004 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1999075 (UMLS CUI [2,4])
Pregnancy Absent | Breast Feeding Absent
Item
neither pregnant nor lactating
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
hba1c 6-10.5% inclusive
boolean
C0474680 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must be practicing adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
PK Objectives Fulfill Unable
Item
inability to meet the pk objectives of the study
boolean
C0031327 (UMLS CUI [1,1])
C0018017 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Loss of hypoglycemic warning | Hypoglycemia Severe
Item
history of hypoglycemia unawareness or severe hypoglycemia
boolean
C0342317 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Increased liver function tests
Item
liver function tests greater than or equal to 2 times the uln
boolean
C0877359 (UMLS CUI [1])
Cardiovascular Diseases | Cerebrovascular Disorders
Item
clinically significant cardiovascular and/or cerebrovascular disease
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
positive test results for hepatitis b, hepatitis c, or hiv
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Hypertensive disease | Hypotension
Item
documented hypertension or hypotension at screening
boolean
C0020538 (UMLS CUI [1])
C0020649 (UMLS CUI [2])
Abnormality of the liver | Biliary tract abnormality
Item
known hepatic or biliary abnormalities
boolean
C4021780 (UMLS CUI [1])
C0549613 (UMLS CUI [2])
Sulfonylureas
Item
current use of sulfonylureas
boolean
C0038766 (UMLS CUI [1])
Tobacco use
Item
active history of tobacco use within 6 months before screening
boolean
C0543414 (UMLS CUI [1])
Blood Donation Excess | Status pre- Albiglutide Dose
Item
donation of blood in excess of 500ml within 56 days before albiglutide dosing
boolean
C0005794 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C2607479 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Investigational New Drugs
Item
receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
boolean
C0013230 (UMLS CUI [1])
Exenatide | GLP-1 Receptor Agonist
Item
previous or current receipt of exenatide or any other glp-1 agonist
boolean
C0167117 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
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