ID

29948

Beschrijving

Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00744237

Link

https://clinicaltrials.gov/show/NCT00744237

Trefwoorden

Versies (2)
  1. 29-04-18 29-04-18 -
  2. 29-04-18 29-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00744237

Engels

Eligibility Hypertension NCT00744237

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18-85 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
blood pressure in the range of 130 to 179/80 to 109 mmhg
Beschrijving

Blood pressure determination

Datatype

boolean

Alias
UMLS CUI [1]
C0005824
currently using either an ace inhibitor or an arb alone or (an ace inhibitor or an arb and up to two other drugs for treatment of high blood pressure). (patients may be on both an ace inhibitor and arb, but would need to be taken off one.)
Beschrijving

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Pharmaceutical Preparations Quantity Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0020538
stable medication regimen for high blood pressure for at least one month prior to screening
Beschrijving

Pharmacotherapy Stable Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0020538
stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Stable Disease length | Diet therapy | Antidiabetics | Insulin Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0872146
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0935929
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
hgba1c 6.5 to 8.5% (this is measured at the screening visit)
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any beta blocker within one month prior to screening
Beschrijving

Adrenergic beta-Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0001645
use of clonidine within 3 months prior to screening
Beschrijving

Clonidine

Datatype

boolean

Alias
UMLS CUI [1]
C0009014
diagnosis of hyperthyroidism as evidenced by abnormal lab markers
Beschrijving

Hyperthyroidism Laboratory Markers Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0162490
UMLS CUI [1,3]
C0205161
any disorder requiring the intermittent or chronic use of systemic corticosteroids
Beschrijving

Disease Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Intermittent | Disease Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [1,4]
C0205267
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3653708
UMLS CUI [2,4]
C0205191
diagnosis of hyperthyroidism as determined by lab markers done at screening
Beschrijving

Hyperthyroidism

Datatype

boolean

Alias
UMLS CUI [1]
C0020550
active liver disease as determined by lab markers
Beschrijving

Liver diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
kidney impairment; estimated gfr < 60 ml/min/1.73 m2
Beschrijving

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
history of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or tia in 3 months prior to screening
Beschrijving

Myocardial Infarction | Cardiac Arrhythmia | Angina, Unstable | Coronary angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0190211
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
chronic heart failure
Beschrijving

Chronic heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0264716
drug or alcohol abuse within 2 years prior to screening
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
history of sensitivity to any beta blocker, hctz, sulfa drug, or calcium channel blocker
Beschrijving

BETA BLOCKER ALLERGY | Hydrochlorothiazide allergy | Allergy to sulfonamides | Calcium-channel blocker allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0741466
UMLS CUI [2]
C0571898
UMLS CUI [3]
C0038757
UMLS CUI [4]
C0570913
participation in another research study within 30 days prior to screening
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Hypertension NCT00744237

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, 18-85 years of age
boolean
C0001779 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure in the range of 130 to 179/80 to 109 mmhg
boolean
C0005824 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Pharmaceutical Preparations Quantity Hypertensive disease
Item
currently using either an ace inhibitor or an arb alone or (an ace inhibitor or an arb and up to two other drugs for treatment of high blood pressure). (patients may be on both an ace inhibitor and arb, but would need to be taken off one.)
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0020538 (UMLS CUI [3,3])
Pharmacotherapy Stable Hypertensive disease
Item
stable medication regimen for high blood pressure for at least one month prior to screening
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
Non-Insulin-Dependent Diabetes Mellitus Stable Disease length | Diet therapy | Antidiabetics | Insulin Dose Stable
Item
stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
boolean
C0011860 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Hemoglobin A1c measurement
Item
hgba1c 6.5 to 8.5% (this is measured at the screening visit)
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adrenergic beta-Antagonists
Item
use of any beta blocker within one month prior to screening
boolean
C0001645 (UMLS CUI [1])
Clonidine
Item
use of clonidine within 3 months prior to screening
boolean
C0009014 (UMLS CUI [1])
Hyperthyroidism Laboratory Markers Abnormal
Item
diagnosis of hyperthyroidism as evidenced by abnormal lab markers
boolean
C0020550 (UMLS CUI [1,1])
C0162490 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Disease Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Intermittent | Disease Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
any disorder requiring the intermittent or chronic use of systemic corticosteroids
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0205267 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3653708 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
Hyperthyroidism
Item
diagnosis of hyperthyroidism as determined by lab markers done at screening
boolean
C0020550 (UMLS CUI [1])
Liver diseases
Item
active liver disease as determined by lab markers
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
kidney impairment; estimated gfr < 60 ml/min/1.73 m2
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Myocardial Infarction | Cardiac Arrhythmia | Angina, Unstable | Coronary angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident | Transient Ischemic Attack
Item
history of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or tia in 3 months prior to screening
boolean
C0027051 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0190211 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
Chronic heart failure
Item
chronic heart failure
boolean
C0264716 (UMLS CUI [1])
Substance Use Disorders
Item
drug or alcohol abuse within 2 years prior to screening
boolean
C0038586 (UMLS CUI [1])
BETA BLOCKER ALLERGY | Hydrochlorothiazide allergy | Allergy to sulfonamides | Calcium-channel blocker allergy
Item
history of sensitivity to any beta blocker, hctz, sulfa drug, or calcium channel blocker
boolean
C0741466 (UMLS CUI [1])
C0571898 (UMLS CUI [2])
C0038757 (UMLS CUI [3])
C0570913 (UMLS CUI [4])
Study Subject Participation Status
Item
participation in another research study within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])
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