ID

29903

Description

Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-Release (ER) for Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00547300

Link

https://clinicaltrials.gov/show/NCT00547300

Keywords

Versions (1)
  1. 4/26/18 4/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00547300

English

Eligibility Hypertension NCT00547300

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, ambulatory outpatients 18-80 yo. females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
Description

Outpatients | Age | Postmenopausal state | Gender Pregnancy Absent | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0032961
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
history of hypertension being treated with two medications, one of which must be hctz and the other of which must not be a beta-blocker or clonidine
Description

Pharmaceutical Preparations Quantity Hypertensive disease | Hydrochlorothiazide | Adrenergic beta-1 Receptor Antagonists Absent | Clonidine Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020538
UMLS CUI [2]
C0020261
UMLS CUI [3,1]
C0304516
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0009014
UMLS CUI [4,2]
C0332197
sbp of 135-155 mm hg and/or dbp of >85 mm hg at screening
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
vision and hearing (hearing aid permissable) sufficient for compliance with testing procedures (i.e., with phone- and/or internet-based assessments)
Description

Vision Sufficient | Hearing Sufficient | Compliance behavior Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C0205410
UMLS CUI [2,1]
C0018767
UMLS CUI [2,2]
C0205410
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0039593
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with a beta-blocker or clonidine within 6 months of screening
Description

Adrenergic beta-1 Receptor Antagonists | Clonidine

Data type

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2]
C0009014
clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
Description

Respiration Disorders | Asthma | Reactive airway disease | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2]
C0004096
UMLS CUI [3]
C3714497
UMLS CUI [4]
C0024117
coronary artery disease requiring treatment with a calcium channel blocker or nitrates
Description

Coronary Artery Disease | Patient need for Calcium Channel Blockers | Patient need for Nitrates

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0006684
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0028125
cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening
Description

Cardiovascular Diseases | Myocardial Infarction | Event Cerebrovascular | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C1880018
UMLS CUI [4]
C0003811
history of severe mental illness (including major depressive disorder, psychosis, dementia, bipolar disorder) within 6 months of screening
Description

Mental Disorders, Severe | Major Depressive Disorder | Psychotic Disorders | Dementia | Bipolar Disorder

Data type

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0005586
use of antipsychotic medicaiton (e.g., dopanine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
Description

Antipsychotic Agents | Dopamine Antagonists | Other Coding | Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0242702
UMLS CUI [3]
C3846158
UMLS CUI [4]
C0003289
diabetes mellitus, type i or ii
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
participation in a previous investigational study of nebivolol at any time
Description

Study Subject Participation Status | Nebivolol

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0068475
receipt of treatment with an investigational study drug within 30 days of screening
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity to nebivolol, metoprolol er, other beta-blockers, hctz, or other sulfonamide-derived drugs
Description

Hypersensitivity Nebivolol | Metoprolol allergy | BETA BLOCKER ALLERGY | Hydrochlorothiazide allergy | Allergy to sulfonamides

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0068475
UMLS CUI [2]
C0570889
UMLS CUI [3]
C0741466
UMLS CUI [4]
C0571898
UMLS CUI [5]
C0038757
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Similar models

Eligibility Hypertension NCT00547300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age | Postmenopausal state | Gender Pregnancy Absent | Gender Contraceptive methods
Item
male or female, ambulatory outpatients 18-80 yo. females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0032961 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Pharmaceutical Preparations Quantity Hypertensive disease | Hydrochlorothiazide | Adrenergic beta-1 Receptor Antagonists Absent | Clonidine Absent
Item
history of hypertension being treated with two medications, one of which must be hctz and the other of which must not be a beta-blocker or clonidine
boolean
C0013227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
C0020261 (UMLS CUI [2])
C0304516 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0009014 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Systolic Pressure | Diastolic blood pressure
Item
sbp of 135-155 mm hg and/or dbp of >85 mm hg at screening
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Vision Sufficient | Hearing Sufficient | Compliance behavior Testing
Item
vision and hearing (hearing aid permissable) sufficient for compliance with testing procedures (i.e., with phone- and/or internet-based assessments)
boolean
C0042789 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0018767 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Adrenergic beta-1 Receptor Antagonists | Clonidine
Item
treatment with a beta-blocker or clonidine within 6 months of screening
boolean
C0304516 (UMLS CUI [1])
C0009014 (UMLS CUI [2])
Respiration Disorders | Asthma | Reactive airway disease | Chronic Obstructive Airway Disease
Item
clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
boolean
C0035204 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C3714497 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
Coronary Artery Disease | Patient need for Calcium Channel Blockers | Patient need for Nitrates
Item
coronary artery disease requiring treatment with a calcium channel blocker or nitrates
boolean
C1956346 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0006684 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0028125 (UMLS CUI [3,2])
Cardiovascular Diseases | Myocardial Infarction | Event Cerebrovascular | Cardiac Arrhythmia
Item
cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C1880018 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
Mental Disorders, Severe | Major Depressive Disorder | Psychotic Disorders | Dementia | Bipolar Disorder
Item
history of severe mental illness (including major depressive disorder, psychosis, dementia, bipolar disorder) within 6 months of screening
boolean
C4046029 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
Antipsychotic Agents | Dopamine Antagonists | Other Coding | Antidepressive Agents
Item
use of antipsychotic medicaiton (e.g., dopanine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
boolean
C0040615 (UMLS CUI [1])
C0242702 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus, type i or ii
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Study Subject Participation Status | Nebivolol
Item
participation in a previous investigational study of nebivolol at any time
boolean
C2348568 (UMLS CUI [1])
C0068475 (UMLS CUI [2])
Investigational New Drugs
Item
receipt of treatment with an investigational study drug within 30 days of screening
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Nebivolol | Metoprolol allergy | BETA BLOCKER ALLERGY | Hydrochlorothiazide allergy | Allergy to sulfonamides
Item
history of hypersensitivity to nebivolol, metoprolol er, other beta-blockers, hctz, or other sulfonamide-derived drugs
boolean
C0020517 (UMLS CUI [1,1])
C0068475 (UMLS CUI [1,2])
C0570889 (UMLS CUI [2])
C0741466 (UMLS CUI [3])
C0571898 (UMLS CUI [4])
C0038757 (UMLS CUI [5])
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