ID

39933

Beschrijving

Comparison of Sevikar® and the Combination of Perindopril/Amlodipine on Central Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT01101009

Link

https://clinicaltrials.gov/show/NCT01101009

Trefwoorden

Versies (1)
  1. 05-03-20 05-03-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 maart 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT01101009

Engels

Eligibility Hypertension NCT01101009

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate to severe hypertension
Beschrijving

Hypertension, moderate | Hypertension, severe

Datatype

boolean

Alias
UMLS CUI [1]
C1969581
UMLS CUI [2]
C4013784
3 additional risk factors such as age > 55 (male), > 65 female, smoker, type 2 diabetes, obesity, cardiovascular disease, congestive heart failure, chronic kidney disease,
Beschrijving

Risk factors Additional Quantity | Age | Gender | Tobacco use | Diabetes Mellitus, Non-Insulin-Dependent | Obesity | Cardiovascular Disease | Congestive heart failure | Chronic Kidney Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0543414
UMLS CUI [5]
C0011860
UMLS CUI [6]
C0028754
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0018802
UMLS CUI [9]
C1561643
ability to give informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary or malignant hypertension
Beschrijving

Secondary hypertension | Malignant Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0020540
contraindication to any of the study drugs
Beschrijving

Medical contraindication Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
creatinine clearance level <40ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
treatment with more than 3 antihypertensive drugs
Beschrijving

Antihypertensive Agents Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac bypass surgery < 6 month prior to start of the study,
Beschrijving

Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C2936173
UMLS CUI [3]
C0010055
unstable angina pectoris,
Beschrijving

Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
stroke, transient ischemic attack < 3 months prior to start,
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
congestive heart failure nyha ii-iv,
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
clinically relevant concomitant diseases,
Beschrijving

Comorbidity Relevance Clinical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
alcohol or drug abuse,
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or women of childbearing potential without contraceptive precaution,
Beschrijving

Pregnancy | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
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Similar models

Eligibility Hypertension NCT01101009

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hypertension, moderate | Hypertension, severe
Item
moderate to severe hypertension
boolean
C1969581 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
Risk factors Additional Quantity | Age | Gender | Tobacco use | Diabetes Mellitus, Non-Insulin-Dependent | Obesity | Cardiovascular Disease | Congestive heart failure | Chronic Kidney Disease
Item
3 additional risk factors such as age > 55 (male), > 65 female, smoker, type 2 diabetes, obesity, cardiovascular disease, congestive heart failure, chronic kidney disease,
boolean
C0035648 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0543414 (UMLS CUI [4])
C0011860 (UMLS CUI [5])
C0028754 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0018802 (UMLS CUI [8])
C1561643 (UMLS CUI [9])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Malignant Hypertension
Item
secondary or malignant hypertension
boolean
C0155616 (UMLS CUI [1])
C0020540 (UMLS CUI [2])
Medical contraindication Investigational New Drugs
Item
contraindication to any of the study drugs
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Creatinine clearance measurement
Item
creatinine clearance level <40ml/min
boolean
C0373595 (UMLS CUI [1])
Antihypertensive Agents Quantity
Item
treatment with more than 3 antihypertensive drugs
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery
Item
myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac bypass surgery < 6 month prior to start of the study,
boolean
C0027051 (UMLS CUI [1])
C2936173 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Angina, Unstable
Item
unstable angina pectoris,
boolean
C0002965 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke, transient ischemic attack < 3 months prior to start,
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure nyha ii-iv,
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Comorbidity Relevance Clinical
Item
clinically relevant concomitant diseases,
boolean
C0009488 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Substance Use Disorders
Item
alcohol or drug abuse,
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or women of childbearing potential without contraceptive precaution,
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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