ID

40704

Description

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

Lien

https://clinicaltrials.gov/show/NCT01087749

Mots-clés

Versions (1)
  1. 01/05/2020 01/05/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

1 mai 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT01087749

Anglais

Eligibility Kidney Disease NCT01087749

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

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

Healthy Volunteers | Chronic Kidney Disease | Glomerular Filtration Rate

Type de données

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.
Description

Informed Consent | Protocol Compliance

Type de données

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.
Description

Avoidance Grapefruit | Avoidance GRAPEFRUIT JUICE

Type de données

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.
Description

Alcohol Abstinence | Abstinence Caffeinated beverage | Abstinence Orange juice

Type de données

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.
Description

Fasting | Fasting Beverages

Type de données

boolean

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

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

Type de données

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
Description

Exclusion Criteria

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

Medical contraindication Investigational New Drugs

Type de données

boolean

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

Propranolol allergy | Losartan allergy | Hypersensitivity Eprosartan

Type de données

boolean

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

Tobacco use

Type de données

boolean

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

Alcohol consumption | Illicit medication use

Type de données

boolean

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

Pregnancy | Breast Feeding | Trying to conceive

Type de données

boolean

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

Contraceptive methods Unable

Type de données

boolean

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

Protocol Compliance Unable

Type de données

boolean

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

Hematocrit level

Type de données

boolean

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

Diabetics Requirement Insulin

Type de données

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)
Description

Low to low-normal blood pressure | Systolic Pressure

Type de données

boolean

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

Uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
Retour au début de la page

Similar models

Eligibility Kidney Disease NCT01087749

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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