ID

30043

Beschrijving

An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION]); ODM derived from: https://clinicaltrials.gov/show/NCT01079962

Link

https://clinicaltrials.gov/show/NCT01079962

Trefwoorden

Versies (2)
  1. 04-05-18 04-05-18 -
  2. 04-05-18 04-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT01079962

Engels

Eligibility Hypertension NCT01079962

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
an antihypertensive-naive subject or a subject who has not been taking the previously administered antihypertensive agent for at least 4 weeks prior to screening
Beschrijving

Antihypertensive Agents naive | Antihypertensive Agents Previous Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C1444662
subjects aged between 20 and 75 years, inclusive
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects with systolic blood pressure (sbp) greater than or equal to 140 millimeter of mercury (mmhg) and less than 180 mmhg or diastolic blood pressure (dbp) greater than or equal to 90 mmhg and less than 110 mmhg
Beschrijving

Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
subjects with renal impairment (creatinine greater than 150 micromoles/liter [mcmol/l] or creatinine greater than 1.7 mg/deciliter [dl])
Beschrijving

Renal Insufficiency | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
subjects with severe hypertension (stage iii) sbp greater than or equal to 180 mmhg or dbp greater than or equal to 110 mmhg
Beschrijving

Severe Hypertension Stage | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0699749
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
subjects with congestive heart failure, acute myocardial infarction, unstable angina
Beschrijving

Congestive heart failure | Myocardial Infarction | Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
subjects with moderate bronchial asthma, chronic obstructive pulmonary disease
Beschrijving

Moderate asthma | Chronic Obstructive Airway Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0581125
UMLS CUI [2]
C0024117
subjects with symptomatic bradycardia, radial artery injury, second degree or third degree atrioventricular (av) block, atrial fibrillation, atrial flutter, left bundle branch block (lbbb)
Beschrijving

BRADYCARDIA SYMPTOMATIC | Injury of radial artery | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Atrial Flutter | Left Bundle-Branch Block

Datatype

boolean

Alias
UMLS CUI [1]
C0741627
UMLS CUI [2]
C0273474
UMLS CUI [3]
C0264906
UMLS CUI [4]
C0151517
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0004239
UMLS CUI [7]
C0023211
subjects with a history of hypersensitivity to bisoprolol and atenolol products
Beschrijving

Bisoprolol allergy | Atenolol allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0570886
UMLS CUI [2]
C0570884
pregnancy or breastfeeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hypertension NCT01079962

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Antihypertensive Agents naive | Antihypertensive Agents Previous Discontinued
Item
an antihypertensive-naive subject or a subject who has not been taking the previously administered antihypertensive agent for at least 4 weeks prior to screening
boolean
C0003364 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Age
Item
subjects aged between 20 and 75 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
subjects with systolic blood pressure (sbp) greater than or equal to 140 millimeter of mercury (mmhg) and less than 180 mmhg or diastolic blood pressure (dbp) greater than or equal to 90 mmhg and less than 110 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
subjects with secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
subjects with renal impairment (creatinine greater than 150 micromoles/liter [mcmol/l] or creatinine greater than 1.7 mg/deciliter [dl])
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Severe Hypertension Stage | Systolic Pressure | Diastolic blood pressure
Item
subjects with severe hypertension (stage iii) sbp greater than or equal to 180 mmhg or dbp greater than or equal to 110 mmhg
boolean
C4013784 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Congestive heart failure | Myocardial Infarction | Angina, Unstable
Item
subjects with congestive heart failure, acute myocardial infarction, unstable angina
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Moderate asthma | Chronic Obstructive Airway Disease
Item
subjects with moderate bronchial asthma, chronic obstructive pulmonary disease
boolean
C0581125 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
BRADYCARDIA SYMPTOMATIC | Injury of radial artery | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Atrial Flutter | Left Bundle-Branch Block
Item
subjects with symptomatic bradycardia, radial artery injury, second degree or third degree atrioventricular (av) block, atrial fibrillation, atrial flutter, left bundle branch block (lbbb)
boolean
C0741627 (UMLS CUI [1])
C0273474 (UMLS CUI [2])
C0264906 (UMLS CUI [3])
C0151517 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0004239 (UMLS CUI [6])
C0023211 (UMLS CUI [7])
Bisoprolol allergy | Atenolol allergy
Item
subjects with a history of hypersensitivity to bisoprolol and atenolol products
boolean
C0570886 (UMLS CUI [1])
C0570884 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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