ID

40118

Description

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

Keywords

Versions (1)
  1. 3/12/20 3/12/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 12, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01682564

English

Eligibility Hypertension NCT01682564

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Congestive heart failure New York Heart Association Classification | Pharmacotherapy

Data type

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
Description

Hypertensive disease | Pharmacotherapy | Systolic Pressure | Diastolic blood pressure

Data type

boolean

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

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)
Description

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

Data type

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
Description

Creatinine measurement

Data type

boolean

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

Blood potassium measurement

Data type

boolean

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

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Premenopausal state Contraceptive methods Absent

Data type

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
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

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

Lactose Intolerance | Lapps Lactase deficiency | Glucose-galactose malabsorption

Data type

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
Description

Investigational New Drugs Other

Data type

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
Description

Myocardial Ischemia | Angina Pectoris | Myocardial Infarction

Data type

boolean

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

Research Personnel Judgment

Data type

boolean

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

Eligibility Hypertension NCT01682564

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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