ID

12974

Description

BIBR 277 Capsule in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02177448

Link

https://clinicaltrials.gov/show/NCT02177448

Keywords

Versions (1)
  1. 1/8/16 1/8/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 8, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT02177448

English

Eligibility Hypertension NCT02177448

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is ≥ 25 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
outpatient. change to inpatient is not allowed during the study period
Description

outpatient

Data type

boolean

Alias
UMLS CUI [1]
C0029921
blood pressure is measured 3 times or more during the 4-week observation period; the last 2 measurements in the sitting position (intervals between measurements must be less than 4 weeks) are stabilized for both of systolic pressure (within +/- 30 mmhg) and diastolic pressure within +/- 15 mmhg) with the mean exceeding 160 mmhg for systolic and 95 mmhg for diastolic pressure
Description

blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has severe hypertension (the last 2 measurements in the observation period exceed 120 mmhg in terms of diastolic blood pressure)
Description

severe hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
patient has secondary or malignant hypertension
Description

patient has secondary or malignant hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
patient has a history of severe cardiac failure, unstable angina, or myocardial infarction within previous six months
Description

heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia
Description

patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
patient has any symptoms of cerebrovascular disorder
Description

cerebrovascular disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007820
patient has serious hepatic dysfunction (either got (glutamic-oxaloacetic transaminase) or gpt (glutamic-pyruvic transaminase) exceeds 100 u)
Description

hepatic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0004002
UMLS CUI [2]
C0001899
patient has renal dysfunction (serum creatinin ≥ 2.1 mg/dl)
Description

renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0201976
patient has uncontrolled diabetic (either of the following tests exceeds the specified standards: fasting blood glucose exceeding 151 mg/dl or hba1c exceeding 8%)
Description

uncontrolled diabetic

Data type

boolean

Alias
UMLS CUI [1]
C0202042
UMLS CUI [2]
C0019018
patient has a history of drug sensitivity to ace (angiotensin converting enzyme) inhibitors and angiotensin ii receptor antagonists
Description

sensitivity to ace

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0521942
patient has a history of angioedema due to ace inhibitors
Description

angioedema due to ace inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0002994
patient has hyperkalemia (k exceeding 5.5 meq/l)
Description

hyperkalemia

Data type

boolean

Alias
UMLS CUI [1]
C0020461
patient has received enalapril just before the start of observation period
Description

enalapril

Data type

boolean

Alias
UMLS CUI [1]
C0014025
patient has received treatment with any other investigational drug(s) within three months of the start of observation period
Description

patient has received treatment with any other investigational drug(s) within three months of the start of observation period

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period
Description

patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation
Description

patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Hypertension NCT02177448

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patient is ≥ 25 years of age
boolean
C0001779 (UMLS CUI [1])
outpatient
Item
outpatient. change to inpatient is not allowed during the study period
boolean
C0029921 (UMLS CUI [1])
blood pressure
Item
blood pressure is measured 3 times or more during the 4-week observation period; the last 2 measurements in the sitting position (intervals between measurements must be less than 4 weeks) are stabilized for both of systolic pressure (within +/- 30 mmhg) and diastolic pressure within +/- 15 mmhg) with the mean exceeding 160 mmhg for systolic and 95 mmhg for diastolic pressure
boolean
C0005823 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
severe hypertension
Item
patient has severe hypertension (the last 2 measurements in the observation period exceed 120 mmhg in terms of diastolic blood pressure)
boolean
C0020538 (UMLS CUI [1])
patient has secondary or malignant hypertension
Item
patient has secondary or malignant hypertension
boolean
C0020538 (UMLS CUI [1])
heart disease
Item
patient has a history of severe cardiac failure, unstable angina, or myocardial infarction within previous six months
boolean
C0018799 (UMLS CUI [1])
patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia
Item
patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia
boolean
C0003811 (UMLS CUI [1])
cerebrovascular disorder
Item
patient has any symptoms of cerebrovascular disorder
boolean
C0007820 (UMLS CUI [1])
hepatic dysfunction
Item
patient has serious hepatic dysfunction (either got (glutamic-oxaloacetic transaminase) or gpt (glutamic-pyruvic transaminase) exceeds 100 u)
boolean
C0004002 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
renal dysfunction
Item
patient has renal dysfunction (serum creatinin ≥ 2.1 mg/dl)
boolean
C0201976 (UMLS CUI [1])
uncontrolled diabetic
Item
patient has uncontrolled diabetic (either of the following tests exceeds the specified standards: fasting blood glucose exceeding 151 mg/dl or hba1c exceeding 8%)
boolean
C0202042 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
sensitivity to ace
Item
patient has a history of drug sensitivity to ace (angiotensin converting enzyme) inhibitors and angiotensin ii receptor antagonists
boolean
C0020517 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
angioedema due to ace inhibitors
Item
patient has a history of angioedema due to ace inhibitors
boolean
C0002994 (UMLS CUI [1])
hyperkalemia
Item
patient has hyperkalemia (k exceeding 5.5 meq/l)
boolean
C0020461 (UMLS CUI [1])
enalapril
Item
patient has received enalapril just before the start of observation period
boolean
C0014025 (UMLS CUI [1])
patient has received treatment with any other investigational drug(s) within three months of the start of observation period
Item
patient has received treatment with any other investigational drug(s) within three months of the start of observation period
boolean
C2348568 (UMLS CUI [1])
patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period
Item
patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation
Item
patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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