ID

39204

Beskrivning

Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01198249

Länk

https://clinicaltrials.gov/show/NCT01198249

Nyckelord

Versioner (1)
  1. 2019-12-10 2019-12-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01198249

Engelsk

Eligibility Essential Hypertension NCT01198249

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects 20-50 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
above 55kg and within ±20% ideal body weight
Beskrivning

Body Weight | Percentage Ideal Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C0439165
UMLS CUI [2,2]
C0421272
subjects who are in average of 130mmhg ≤ systolic blood pressure (sbp) < 160mmhg, 80mmhg ≤ diastolic blood pressure (dbp) < 100mmhg
Beskrivning

Average Systolic Pressure | Average Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0871470
UMLS CUI [2,1]
C1510992
UMLS CUI [2,2]
C0428883
female subject who confirmed non-pregnant status and agree to comply with proper contraception.
Beskrivning

Gender Pregnancy Absent | Gender Compliance Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0700589
subjects who wrote informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are suspected to have acute disease
Beskrivning

Acute illness Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0750491
subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
Beskrivning

Medical History Affecting Drug absorption | Medical History Affecting Drug distribution | Medical History Affecting Drug metabolism | Medical History Affecting Drug elimination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0683141
subjects who have gastrointestinal history
Beskrivning

History of gastrointestinal disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0455553
subjects whose heartrate is less than 60
Beskrivning

Heart rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0018810
subject who suspected to orthostatic hypotension
Beskrivning

Orthostatic Hypotension Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0750491
subjects who have clinically significant allergy disease
Beskrivning

Hypersensitivity Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2826293
subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
administration of prescription drug within 14 days or over the counter (otc) drug within 7 days
Beskrivning

Administration of medication Recent | Take non-prescription medications Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C3843194
UMLS CUI [2,2]
C0332185
subjects who have past history of drug abuse and positive in drug screening test
Beskrivning

History of drug abuse | Drug screen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C1299544
UMLS CUI [2]
C0743295
subjects who donate whole blood within 60 days and platelet within 30days.
Beskrivning

Blood donation Recent | Platelet donation Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4316802
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0005821
UMLS CUI [2,2]
C0680854
UMLS CUI [2,3]
C0332185
subjects taking st john's wort or cyp inhibitor and inducer
Beskrivning

ST. JOHN'S WORT EXTRACT | Cytochrome P-450 Enzyme Inhibitors | Cytochrome P450 Inducers

Datatyp

boolean

Alias
UMLS CUI [1]
C0813171
UMLS CUI [2]
C3850070
UMLS CUI [3]
C3500477
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Similar models

Eligibility Essential Hypertension NCT01198249

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult subjects 20-50 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body Weight | Percentage Ideal Body Weight
Item
above 55kg and within ±20% ideal body weight
boolean
C0005910 (UMLS CUI [1])
C0439165 (UMLS CUI [2,1])
C0421272 (UMLS CUI [2,2])
Average Systolic Pressure | Average Diastolic blood pressure
Item
subjects who are in average of 130mmhg ≤ systolic blood pressure (sbp) < 160mmhg, 80mmhg ≤ diastolic blood pressure (dbp) < 100mmhg
boolean
C1510992 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C1510992 (UMLS CUI [2,1])
C0428883 (UMLS CUI [2,2])
Gender Pregnancy Absent | Gender Compliance Contraceptive methods
Item
female subject who confirmed non-pregnant status and agree to comply with proper contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Informed Consent
Item
subjects who wrote informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute illness Suspected
Item
subjects who are suspected to have acute disease
boolean
C4061114 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Medical History Affecting Drug absorption | Medical History Affecting Drug distribution | Medical History Affecting Drug metabolism | Medical History Affecting Drug elimination
Item
subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
boolean
C0262926 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
History of gastrointestinal disease
Item
subjects who have gastrointestinal history
boolean
C0455553 (UMLS CUI [1])
Heart rate
Item
subjects whose heartrate is less than 60
boolean
C0018810 (UMLS CUI [1])
Orthostatic Hypotension Suspected
Item
subject who suspected to orthostatic hypotension
boolean
C0020651 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Hypersensitivity Clinical Significance
Item
subjects who have clinically significant allergy disease
boolean
C0020517 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Administration of medication Recent | Take non-prescription medications Recent
Item
administration of prescription drug within 14 days or over the counter (otc) drug within 7 days
boolean
C3469597 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3843194 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
History of drug abuse | Drug screen positive
Item
subjects who have past history of drug abuse and positive in drug screening test
boolean
C1299544 (UMLS CUI [1])
C0743295 (UMLS CUI [2])
Blood donation Recent | Platelet donation Recent
Item
subjects who donate whole blood within 60 days and platelet within 30days.
boolean
C4316802 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0005821 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
ST. JOHN'S WORT EXTRACT | Cytochrome P-450 Enzyme Inhibitors | Cytochrome P450 Inducers
Item
subjects taking st john's wort or cyp inhibitor and inducer
boolean
C0813171 (UMLS CUI [1])
C3850070 (UMLS CUI [2])
C3500477 (UMLS CUI [3])
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