ID

30006

Beskrivning

Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01012479

Länk

https://clinicaltrials.gov/show/NCT01012479

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

4 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT01012479

Engelsk

Eligibility Hypertension NCT01012479

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of essential hypertension.
Beskrivning

Essential Hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0085580
has systolic blood pressure between 150 mmhg and 200 mmhg and diastolic blood pressure between 110 mmhg and 120 mmhg.
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
has not received any antihypertensive treatment so far.
Beskrivning

Antihypertensive therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0332197
has a negative pregnancy test at baseline in females of childbearing potential. male and female participants with reproductive potential must use an approved contraceptive method during study treatment evaluation
Beskrivning

Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a known or suspected secondary hypertension or primary hyperaldosteronism.
Beskrivning

Secondary hypertension | Conn Syndrome | Secondary hypertension Suspected | Conn Syndrome Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C1384514
UMLS CUI [3,1]
C0155616
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C1384514
UMLS CUI [4,2]
C0750491
has impaired renal function.
Beskrivning

Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
has severe hepatic impairment.
Beskrivning

Hepatic impairment Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
has bilateral renal artery stenosis, solitary kidney or post-renal transplant status.
Beskrivning

Bilateral renal artery stenosis | Kidney Solitary | Status post Kidney Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0856760
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0022671
has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention or cerebral accident (stroke or transient ischaemic attack) within the last 6 months.
Beskrivning

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
has a diagnosis or suspicion of the following conditions: hypertrophic obstructive cardiomyopathy, angina pectoris, chronic heart failure, peripheral arterial occlusive disease, hypertensive retinopathy.
Beskrivning

Hypertrophic Cardiomyopathy | Angina Pectoris | Chronic heart failure | Peripheral arterial occlusive disease | Hypertensive Retinopathy | Hypertrophic Cardiomyopathy Suspicion | Angina Pectoris Suspicion | Chronic heart failure Suspicion | Peripheral arterial occlusive disease Suspicion | Hypertensive Retinopathy Suspicion

Datatyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0264716
UMLS CUI [4]
C1306889
UMLS CUI [5]
C0152132
UMLS CUI [6,1]
C0007194
UMLS CUI [6,2]
C0242114
UMLS CUI [7,1]
C0002962
UMLS CUI [7,2]
C0242114
UMLS CUI [8,1]
C0264716
UMLS CUI [8,2]
C0242114
UMLS CUI [9,1]
C1306889
UMLS CUI [9,2]
C0242114
UMLS CUI [10,1]
C0152132
UMLS CUI [10,2]
C0242114
has hemodynamically relevant stenosis of the aortic or mitral valve.
Beskrivning

Aortic Valve Stenosis | Mitral Valve Stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C0026269
has clinically relevant and refractory hypokalaemia or hyperkalaemia.
Beskrivning

Hypokalemia refractory | Hyperkalemia refractory

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020621
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0020461
UMLS CUI [2,2]
C0205269
has uncorrected volume or sodium depletion.
Beskrivning

Hypovolemia uncorrected | Hyponatremia uncorrected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0546884
UMLS CUI [1,2]
C4072785
UMLS CUI [2,1]
C0020625
UMLS CUI [2,2]
C4072785
has gout or relevant hyperuricaemia.
Beskrivning

Gout | Hyperuricemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0740394
has a known intolerance/hypersensitivity to candesartan cilexetil or hydrochlorothiazide.
Beskrivning

Intolerance to Candesartan cilexetil | Hypersensitivity Candesartan cilexetil | Intolerance to Hydrochlorothiazide | Hydrochlorothiazide allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0527379
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0527379
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0020261
UMLS CUI [4]
C0571898
has a known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Beskrivning

Galactosemias | Lactase deficiency | Glucose-galactose malabsorption

Datatyp

boolean

Alias
UMLS CUI [1]
C0016952
UMLS CUI [2]
C0302813
UMLS CUI [3]
C0268186
is taking psychotropic medication or is addicted to alcohol or drugs.
Beskrivning

Psychotropic Drugs | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0038580
has participated in another trial of an investigational drug or a medical device within the last 30 days or is currently participating in another trial of an investigational drug or a medical device.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Hypertension NCT01012479

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
confirmed diagnosis of essential hypertension.
boolean
C0085580 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
has systolic blood pressure between 150 mmhg and 200 mmhg and diastolic blood pressure between 110 mmhg and 120 mmhg.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Antihypertensive therapy Absent
Item
has not received any antihypertensive treatment so far.
boolean
C0585941 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods
Item
has a negative pregnancy test at baseline in females of childbearing potential. male and female participants with reproductive potential must use an approved contraceptive method during study treatment evaluation
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Conn Syndrome | Secondary hypertension Suspected | Conn Syndrome Suspected
Item
has a known or suspected secondary hypertension or primary hyperaldosteronism.
boolean
C0155616 (UMLS CUI [1])
C1384514 (UMLS CUI [2])
C0155616 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C1384514 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Renal Insufficiency
Item
has impaired renal function.
boolean
C1565489 (UMLS CUI [1])
Hepatic impairment Severe
Item
has severe hepatic impairment.
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Bilateral renal artery stenosis | Kidney Solitary | Status post Kidney Transplantation
Item
has bilateral renal artery stenosis, solitary kidney or post-renal transplant status.
boolean
C0856760 (UMLS CUI [1])
C0022646 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0022671 (UMLS CUI [3,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Cerebrovascular accident | Transient Ischemic Attack
Item
has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention or cerebral accident (stroke or transient ischaemic attack) within the last 6 months.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
Hypertrophic Cardiomyopathy | Angina Pectoris | Chronic heart failure | Peripheral arterial occlusive disease | Hypertensive Retinopathy | Hypertrophic Cardiomyopathy Suspicion | Angina Pectoris Suspicion | Chronic heart failure Suspicion | Peripheral arterial occlusive disease Suspicion | Hypertensive Retinopathy Suspicion
Item
has a diagnosis or suspicion of the following conditions: hypertrophic obstructive cardiomyopathy, angina pectoris, chronic heart failure, peripheral arterial occlusive disease, hypertensive retinopathy.
boolean
C0007194 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0264716 (UMLS CUI [3])
C1306889 (UMLS CUI [4])
C0152132 (UMLS CUI [5])
C0007194 (UMLS CUI [6,1])
C0242114 (UMLS CUI [6,2])
C0002962 (UMLS CUI [7,1])
C0242114 (UMLS CUI [7,2])
C0264716 (UMLS CUI [8,1])
C0242114 (UMLS CUI [8,2])
C1306889 (UMLS CUI [9,1])
C0242114 (UMLS CUI [9,2])
C0152132 (UMLS CUI [10,1])
C0242114 (UMLS CUI [10,2])
Aortic Valve Stenosis | Mitral Valve Stenosis
Item
has hemodynamically relevant stenosis of the aortic or mitral valve.
boolean
C0003507 (UMLS CUI [1])
C0026269 (UMLS CUI [2])
Hypokalemia refractory | Hyperkalemia refractory
Item
has clinically relevant and refractory hypokalaemia or hyperkalaemia.
boolean
C0020621 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0020461 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Hypovolemia uncorrected | Hyponatremia uncorrected
Item
has uncorrected volume or sodium depletion.
boolean
C0546884 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0020625 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
Gout | Hyperuricemia
Item
has gout or relevant hyperuricaemia.
boolean
C0018099 (UMLS CUI [1])
C0740394 (UMLS CUI [2])
Intolerance to Candesartan cilexetil | Hypersensitivity Candesartan cilexetil | Intolerance to Hydrochlorothiazide | Hydrochlorothiazide allergy
Item
has a known intolerance/hypersensitivity to candesartan cilexetil or hydrochlorothiazide.
boolean
C1744706 (UMLS CUI [1,1])
C0527379 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0527379 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0020261 (UMLS CUI [3,2])
C0571898 (UMLS CUI [4])
Galactosemias | Lactase deficiency | Glucose-galactose malabsorption
Item
has a known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
boolean
C0016952 (UMLS CUI [1])
C0302813 (UMLS CUI [2])
C0268186 (UMLS CUI [3])
Psychotropic Drugs | Substance Dependence
Item
is taking psychotropic medication or is addicted to alcohol or drugs.
boolean
C0033978 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
has participated in another trial of an investigational drug or a medical device within the last 30 days or is currently participating in another trial of an investigational drug or a medical device.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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