ID

40118

Descrição

To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01682564

Link

https://clinicaltrials.gov/show/NCT01682564

Palavras-chave

Versões (1)
  1. 12/03/2020 12/03/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de março de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT01682564

Inglês

Eligibility Hypertension NCT01682564

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to provide written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
age 20 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient with congestive heart failure, taking treatment medicine and nyha grade ii~iii
Descrição

Congestive heart failure New York Heart Association Classification | Pharmacotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0013216
patient with hypertension, taking treatment medicine or sbp ≥ 140mmhg or dbp ≥ 90mmhg at the screening visit
Descrição

Hypertensive disease | Pharmacotherapy | Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0013216
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease)
Descrição

Secondary hypertension | Secondary hypertension Suspected | Aortic coarctation | Conn Syndrome | Renal Artery Stenosis | Pheochromocytoma | Cushing Syndrome | Polycystic Kidney Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0003492
UMLS CUI [4]
C1384514
UMLS CUI [5]
C0035067
UMLS CUI [6]
C0031511
UMLS CUI [7]
C0010481
UMLS CUI [8]
C0022680
blood creatinine level ≥ 2.5mg/dl
Descrição

Creatinine measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201975
blood potassium level > 5.5meq/l
Descrição

Blood potassium measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0729816
blood sgot, sgpt level ≥ maximum normal range x3 or patient with sever hepatic dysfunction, cholestasis
Descrição

Aspartate aminotransferase increased | Alanine aminotransferase increased | Liver Dysfunction Severe | Cholestasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0008370
pregnant or breast-feeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
premenopausal women not using adequate contraception
Descrição

Premenopausal state Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
patient has history about hypersensitivity or taboo of investigational product
Descrição

Hypersensitivity Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
patient with lactose intolerance or lapp lactase deficiency or glucode-galactose malabsorption
Descrição

Lactose Intolerance | Lapps Lactase deficiency | Glucose-galactose malabsorption

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022951
UMLS CUI [2,1]
C0337904
UMLS CUI [2,2]
C0302813
UMLS CUI [3]
C0268186
administration of other study drugs within 1 month prior to screening
Descrição

Investigational New Drugs Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months
Descrição

Myocardial Ischemia | Angina Pectoris | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
in investigator's judgement
Descrição

Research Personnel Judgment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0022423
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Similar models

Eligibility Hypertension NCT01682564

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age 20 years or older
boolean
C0001779 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification | Pharmacotherapy
Item
patient with congestive heart failure, taking treatment medicine and nyha grade ii~iii
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2])
Hypertensive disease | Pharmacotherapy | Systolic Pressure | Diastolic blood pressure
Item
patient with hypertension, taking treatment medicine or sbp ≥ 140mmhg or dbp ≥ 90mmhg at the screening visit
boolean
C0020538 (UMLS CUI [1])
C0013216 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Secondary hypertension Suspected | Aortic coarctation | Conn Syndrome | Renal Artery Stenosis | Pheochromocytoma | Cushing Syndrome | Polycystic Kidney Diseases
Item
known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease)
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0003492 (UMLS CUI [3])
C1384514 (UMLS CUI [4])
C0035067 (UMLS CUI [5])
C0031511 (UMLS CUI [6])
C0010481 (UMLS CUI [7])
C0022680 (UMLS CUI [8])
Creatinine measurement
Item
blood creatinine level ≥ 2.5mg/dl
boolean
C0201975 (UMLS CUI [1])
Blood potassium measurement
Item
blood potassium level > 5.5meq/l
boolean
C0729816 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Liver Dysfunction Severe | Cholestasis
Item
blood sgot, sgpt level ≥ maximum normal range x3 or patient with sever hepatic dysfunction, cholestasis
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0008370 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Premenopausal state Contraceptive methods Absent
Item
premenopausal women not using adequate contraception
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
patient has history about hypersensitivity or taboo of investigational product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Lactose Intolerance | Lapps Lactase deficiency | Glucose-galactose malabsorption
Item
patient with lactose intolerance or lapp lactase deficiency or glucode-galactose malabsorption
boolean
C0022951 (UMLS CUI [1])
C0337904 (UMLS CUI [2,1])
C0302813 (UMLS CUI [2,2])
C0268186 (UMLS CUI [3])
Investigational New Drugs Other
Item
administration of other study drugs within 1 month prior to screening
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Myocardial Ischemia | Angina Pectoris | Myocardial Infarction
Item
history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months
boolean
C0151744 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Research Personnel Judgment
Item
in investigator's judgement
boolean
C0035173 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
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