ID

30042

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01079962

Nyckelord

Versioner (2)
  1. 2018-05-04 2018-05-04 -
  2. 2018-05-04 2018-05-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 maj 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT01079962

Engelsk

Eligibility Hypertension NCT01079962

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

Antihypertensive Agents naive | Antihypertensive Agents Previous Absent

Datatyp

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]
C0332197
subjects aged between 20 and 75 years, inclusive
Beskrivning

Age

Datatyp

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
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with secondary hypertension
Beskrivning

Secondary hypertension

Datatyp

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])
Beskrivning

Renal Insufficiency | Creatinine measurement, serum

Datatyp

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
Beskrivning

Severe Hypertension Stage | Systolic Pressure | Diastolic blood pressure

Datatyp

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
Beskrivning

Congestive heart failure | Myocardial Infarction | Angina, Unstable

Datatyp

boolean

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

Moderate asthma | Chronic Obstructive Airway Disease

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Bisoprolol allergy | Atenolol allergy

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

Eligibility Hypertension NCT01079962

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Antihypertensive Agents naive | Antihypertensive Agents Previous Absent
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])
C0332197 (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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