ID

24153

Beskrivning

The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00438945

Länk

https://clinicaltrials.gov/show/NCT00438945

Nyckelord

Versioner (1)
  1. 2017-07-26 2017-07-26 -
Uppladdad den

26 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00438945

Engelsk

Eligibility Essential Hypertension NCT00438945

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 - 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index less or equal to 30 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
Beskrivning

Gender | Contraceptives, Oral, Hormonal | Intrauterine Devices | Female Sterilization | Hysterectomy | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0009907
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0232970
arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmhg systolic or above 80 mmhg diastolic.
Beskrivning

Hypertensive disease | Blood pressure ambulatory 24 hour Systolic | Blood pressure ambulatory 24 hour Diastolic

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0855316
UMLS CUI [2,2]
C0439584
UMLS CUI [2,3]
C0039155
UMLS CUI [3,1]
C0855316
UMLS CUI [3,2]
C0439584
UMLS CUI [3,3]
C0012000
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of myocardial infarction.
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
history of stroke.
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
heart failure.
Beskrivning

Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
endocrine organ disease.
Beskrivning

Endocrine System Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0014130
lung disease.
Beskrivning

Lung disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
clinically significant abnormal biochemical screening of the blood regarding: b-hemoglobin, p-sodium, p-potassium, p-creatinine (under 200 µmol/l will be accepted), p-albumin, p-bilirubin, p-alaninaminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
Beskrivning

Blood test abnormal Biochemical | Hemoglobin B measurement | Sodium measurement | Potassium measurement | Creatinine measurement, serum | Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Cholesterol measurement test | Glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0854146
UMLS CUI [1,2]
C0205474
UMLS CUI [2]
C2984939
UMLS CUI [3]
C0337443
UMLS CUI [4]
C0202194
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0201838
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201850
UMLS CUI [10]
C0201950
UMLS CUI [11]
C0337438
clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/l will be accepted).
Beskrivning

Urine screening abnormal | Urine albumin level | Glucose measurement, urine | Total Protein Urine Excretion Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0438142
UMLS CUI [2]
C0587185
UMLS CUI [3]
C0004076
UMLS CUI [4]
C3897352
renovascular hypertension.
Beskrivning

Hypertension, Renovascular

Datatyp

boolean

Alias
UMLS CUI [1]
C0020545
malignant disease.
Beskrivning

malignant disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0442867
alcohol abuse.
Beskrivning

Alcohol abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
usage of medical drugs besides antihypertensives or statins.
Beskrivning

Pharmaceutical Preparations Antihypertensive Agents Excluded | Pharmaceutical Preparations Statins Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0003364
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0360714
UMLS CUI [2,3]
C2828389
drug abuse.
Beskrivning

Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
pregnancy or breast feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known intolerance or allergic to eprosartan or sodium nitroprusside.
Beskrivning

Intolerance to Eprosartan | Allergic Reaction Eprosartan | Intolerance to Sodium Nitroprusside | Sodium nitroprusside allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0287041
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0287041
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0037533
UMLS CUI [4]
C0571973
blood donation within 1 month of the start of the study.
Beskrivning

Blood Donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
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Similar models

Eligibility Essential Hypertension NCT00438945

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 - 65 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index less or equal to 30 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Gender | Contraceptives, Oral, Hormonal | Intrauterine Devices | Female Sterilization | Hysterectomy | Postmenopausal state
Item
women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
boolean
C0079399 (UMLS CUI [1])
C0009907 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
Hypertensive disease | Blood pressure ambulatory 24 hour Systolic | Blood pressure ambulatory 24 hour Diastolic
Item
arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmhg systolic or above 80 mmhg diastolic.
boolean
C0020538 (UMLS CUI [1])
C0855316 (UMLS CUI [2,1])
C0439584 (UMLS CUI [2,2])
C0039155 (UMLS CUI [2,3])
C0855316 (UMLS CUI [3,1])
C0439584 (UMLS CUI [3,2])
C0012000 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
history of myocardial infarction.
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
history of stroke.
boolean
C0038454 (UMLS CUI [1])
Heart failure
Item
heart failure.
boolean
C0018801 (UMLS CUI [1])
Endocrine System Diseases
Item
endocrine organ disease.
boolean
C0014130 (UMLS CUI [1])
Lung disease
Item
lung disease.
boolean
C0024115 (UMLS CUI [1])
Blood test abnormal Biochemical | Hemoglobin B measurement | Sodium measurement | Potassium measurement | Creatinine measurement, serum | Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Cholesterol measurement test | Glucose measurement
Item
clinically significant abnormal biochemical screening of the blood regarding: b-hemoglobin, p-sodium, p-potassium, p-creatinine (under 200 µmol/l will be accepted), p-albumin, p-bilirubin, p-alaninaminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
boolean
C0854146 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C2984939 (UMLS CUI [2])
C0337443 (UMLS CUI [3])
C0202194 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0201838 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201850 (UMLS CUI [9])
C0201950 (UMLS CUI [10])
C0337438 (UMLS CUI [11])
Urine screening abnormal | Urine albumin level | Glucose measurement, urine | Total Protein Urine Excretion Rate
Item
clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/l will be accepted).
boolean
C0438142 (UMLS CUI [1])
C0587185 (UMLS CUI [2])
C0004076 (UMLS CUI [3])
C3897352 (UMLS CUI [4])
Hypertension, Renovascular
Item
renovascular hypertension.
boolean
C0020545 (UMLS CUI [1])
malignant disease
Item
malignant disease.
boolean
C0442867 (UMLS CUI [1])
Alcohol abuse
Item
alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Pharmaceutical Preparations Antihypertensive Agents Excluded | Pharmaceutical Preparations Statins Excluded
Item
usage of medical drugs besides antihypertensives or statins.
boolean
C0013227 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Drug abuse
Item
drug abuse.
boolean
C0013146 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intolerance to Eprosartan | Allergic Reaction Eprosartan | Intolerance to Sodium Nitroprusside | Sodium nitroprusside allergy
Item
known intolerance or allergic to eprosartan or sodium nitroprusside.
boolean
C1744706 (UMLS CUI [1,1])
C0287041 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0287041 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0037533 (UMLS CUI [3,2])
C0571973 (UMLS CUI [4])
Blood Donation
Item
blood donation within 1 month of the start of the study.
boolean
C0005794 (UMLS CUI [1])
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