ID

40085

Descripción

Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg; ODM derived from: https://clinicaltrials.gov/show/NCT01611077

Link

https://clinicaltrials.gov/show/NCT01611077

Palabras clave

Versiones (1)
  1. 11/3/20 11/3/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de marzo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT01611077

Inglés

Eligibility Hypertension NCT01611077

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients >= 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
essential hypertension, i. e. systolic office bp >= 140 mmhg for pre-treated patients or >= 160 mmhg for untreated patients at screening visit and >= 160 mmhg at end of wash-out
Descripción

Essential Hypertension | Systolic Pressure | Patients pre treatment | Patients untreated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0871470
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C2709094
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0332155
signed ic
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
systolic office bp > 180 mm hg at screening visit
Descripción

Systolic Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
known hypertensive retinopathy giii or iv
Descripción

Hypertensive Retinopathy Grade

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
Descripción

Myocardial Infarction | Indication Coronary revascularisation | Indication Peripheral revascularisation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0877341
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1096418
type i diabetes or poorly controlled (hba1c >= 8) type ii diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0474680
chronic heart failure nyha iii or iv
Descripción

Chronic heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
prior stroke or tia
Descripción

Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
creatinine clearance < 60 ml/min or condition after kidney transplant
Descripción

Creatinine clearance measurement | Condition Post Kidney Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0022671
moderately or severely impaired liver function (alt or ast or bilirubin more than double normal value)
Descripción

Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0741494
women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
Descripción

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
concomitant therapy with lithium
Descripción

Lithium therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0204592
hemodynamically relevant mitral or aortic valve stenosis (>= ii°) or hypertrophic obstructive cardiomyopathy
Descripción

Mitral Valve Stenosis | Aortic Valve Stenosis | Hypertrophic Cardiomyopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026269
UMLS CUI [2]
C0003507
UMLS CUI [3]
C0007194
concomitant therapy with strong cyp3a4 inhibitors or inductors
Descripción

CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
african patients
Descripción

Patients African

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0027567
concomitant severe psychiatric condition that might impair proper intake of study medication
Descripción

Severe Mental Disorders Impairing Intake Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4046029
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C1512806
UMLS CUI [1,4]
C0013230
life expectancy < 6 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
night shift workers
Descripción

Night shift worker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0555008
known other mandatory indication for treatment with antihypertensive medications
Descripción

Indication Antihypertensive therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0585941
parallel participation in other clinical trials
Descripción

Study Subject Participation Status | Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Hypertension NCT01611077

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension | Systolic Pressure | Patients pre treatment | Patients untreated
Item
essential hypertension, i. e. systolic office bp >= 140 mmhg for pre-treated patients or >= 160 mmhg for untreated patients at screening visit and >= 160 mmhg at end of wash-out
boolean
C0085580 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C2709094 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
Informed Consent
Item
signed ic
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
systolic office bp > 180 mm hg at screening visit
boolean
C0871470 (UMLS CUI [1])
Hypertensive Retinopathy Grade
Item
known hypertensive retinopathy giii or iv
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Myocardial Infarction | Indication Coronary revascularisation | Indication Peripheral revascularisation
Item
recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
boolean
C0027051 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0877341 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C1096418 (UMLS CUI [3,2])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement
Item
type i diabetes or poorly controlled (hba1c >= 8) type ii diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Chronic heart failure New York Heart Association Classification
Item
chronic heart failure nyha iii or iv
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
prior stroke or tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Creatinine clearance measurement | Condition Post Kidney Transplantation
Item
creatinine clearance < 60 ml/min or condition after kidney transplant
boolean
C0373595 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0022671 (UMLS CUI [2,3])
Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
moderately or severely impaired liver function (alt or ast or bilirubin more than double normal value)
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0741494 (UMLS CUI [5])
Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding
Item
women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Lithium therapy
Item
concomitant therapy with lithium
boolean
C0204592 (UMLS CUI [1])
Mitral Valve Stenosis | Aortic Valve Stenosis | Hypertrophic Cardiomyopathy
Item
hemodynamically relevant mitral or aortic valve stenosis (>= ii°) or hypertrophic obstructive cardiomyopathy
boolean
C0026269 (UMLS CUI [1])
C0003507 (UMLS CUI [2])
C0007194 (UMLS CUI [3])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
concomitant therapy with strong cyp3a4 inhibitors or inductors
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Patients African
Item
african patients
boolean
C0030705 (UMLS CUI [1,1])
C0027567 (UMLS CUI [1,2])
Severe Mental Disorders Impairing Intake Investigational New Drugs
Item
concomitant severe psychiatric condition that might impair proper intake of study medication
boolean
C4046029 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Life Expectancy
Item
life expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Night shift worker
Item
night shift workers
boolean
C0555008 (UMLS CUI [1])
Indication Antihypertensive therapy
Item
known other mandatory indication for treatment with antihypertensive medications
boolean
C3146298 (UMLS CUI [1,1])
C0585941 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trials
Item
parallel participation in other clinical trials
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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