ID

40704

Beskrivning

Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01087749

Länk

https://clinicaltrials.gov/show/NCT01087749

Nyckelord

Versioner (1)
  1. 2020-05-01 2020-05-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT01087749

Engelsk

Eligibility Kidney Disease NCT01087749

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female 18-70 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
healthy volunteers or chronic kidney disease (gfr<40)
Beskrivning

Healthy Volunteers | Chronic Kidney Disease | Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C1561643
UMLS CUI [3]
C0017654
be able to provide written informed consent and comply with requirements of the study.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
avoid eating grapefruit and drinking grapefruit juice from 7 days prior to the first study day until completion of the study.
Beskrivning

Avoidance Grapefruit | Avoidance GRAPEFRUIT JUICE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0995150
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0452456
abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of the study day.
Beskrivning

Alcohol Abstinence | Abstinence Caffeinated beverage | Abstinence Orange juice

Datatyp

boolean

Alias
UMLS CUI [1]
C0678274
UMLS CUI [2,1]
C3843422
UMLS CUI [2,2]
C0678438
UMLS CUI [3,1]
C3843422
UMLS CUI [3,2]
C0452458
fast from food and beverages at least 8 hours prior to medication dosing.
Beskrivning

Fasting | Fasting Beverages

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2,1]
C0015663
UMLS CUI [2,2]
C0005329
be able to read, speak, and understand english.
Beskrivning

Able to read English Language | Able to speak English Language | Comprehension English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with contraindications to taking the study drugs
Beskrivning

Medical contraindication Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
subjects with known allergies to propranolol, losartan, or eprosartan.
Beskrivning

Propranolol allergy | Losartan allergy | Hypersensitivity Eprosartan

Datatyp

boolean

Alias
UMLS CUI [1]
C0570901
UMLS CUI [2]
C0571952
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0287041
subjects who smoke tobacco.
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
subjects with ongoing alcohol or illegal drug use.
Beskrivning

Alcohol consumption | Illicit medication use

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0281875
subjects who are pregnant, lactating, or attempting to conceive.
Beskrivning

Pregnancy | Breast Feeding | Trying to conceive

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0420843
subjects unable to maintain adequate birth control during the study.
Beskrivning

Contraceptive methods Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1299582
subjects unable to follow protocol instructions or protocol criteria.
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
subjects with hematocrit < 30mg/dl.
Beskrivning

Hematocrit level

Datatyp

boolean

Alias
UMLS CUI [1]
C0518014
subjects who are insulin requiring diabetics.
Beskrivning

Diabetics Requirement Insulin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241863
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021641
subjects with low, or low normal blood pressure (systolic blood pressure [bp] <100mmhg)
Beskrivning

Low to low-normal blood pressure | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C4540084
UMLS CUI [2]
C0871470
subjects with uncontrolled high blood pressure.
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
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Similar models

Eligibility Kidney Disease NCT01087749

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female 18-70 years of age.
boolean
C0001779 (UMLS CUI [1])
Healthy Volunteers | Chronic Kidney Disease | Glomerular Filtration Rate
Item
healthy volunteers or chronic kidney disease (gfr<40)
boolean
C1708335 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
Informed Consent | Protocol Compliance
Item
be able to provide written informed consent and comply with requirements of the study.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Avoidance Grapefruit | Avoidance GRAPEFRUIT JUICE
Item
avoid eating grapefruit and drinking grapefruit juice from 7 days prior to the first study day until completion of the study.
boolean
C0870186 (UMLS CUI [1,1])
C0995150 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0452456 (UMLS CUI [2,2])
Alcohol Abstinence | Abstinence Caffeinated beverage | Abstinence Orange juice
Item
abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of the study day.
boolean
C0678274 (UMLS CUI [1])
C3843422 (UMLS CUI [2,1])
C0678438 (UMLS CUI [2,2])
C3843422 (UMLS CUI [3,1])
C0452458 (UMLS CUI [3,2])
Fasting | Fasting Beverages
Item
fast from food and beverages at least 8 hours prior to medication dosing.
boolean
C0015663 (UMLS CUI [1])
C0015663 (UMLS CUI [2,1])
C0005329 (UMLS CUI [2,2])
Able to read English Language | Able to speak English Language | Comprehension English Language
Item
be able to read, speak, and understand english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Investigational New Drugs
Item
subjects with contraindications to taking the study drugs
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Propranolol allergy | Losartan allergy | Hypersensitivity Eprosartan
Item
subjects with known allergies to propranolol, losartan, or eprosartan.
boolean
C0570901 (UMLS CUI [1])
C0571952 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0287041 (UMLS CUI [3,2])
Tobacco use
Item
subjects who smoke tobacco.
boolean
C0543414 (UMLS CUI [1])
Alcohol consumption | Illicit medication use
Item
subjects with ongoing alcohol or illegal drug use.
boolean
C0001948 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
Pregnancy | Breast Feeding | Trying to conceive
Item
subjects who are pregnant, lactating, or attempting to conceive.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0420843 (UMLS CUI [3])
Contraceptive methods Unable
Item
subjects unable to maintain adequate birth control during the study.
boolean
C0700589 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Protocol Compliance Unable
Item
subjects unable to follow protocol instructions or protocol criteria.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hematocrit level
Item
subjects with hematocrit < 30mg/dl.
boolean
C0518014 (UMLS CUI [1])
Diabetics Requirement Insulin
Item
subjects who are insulin requiring diabetics.
boolean
C0241863 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
Low to low-normal blood pressure | Systolic Pressure
Item
subjects with low, or low normal blood pressure (systolic blood pressure [bp] <100mmhg)
boolean
C4540084 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Uncontrolled hypertension
Item
subjects with uncontrolled high blood pressure.
boolean
C1868885 (UMLS CUI [1])
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