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ID

12974

Description

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

Lien

https://clinicaltrials.gov/show/NCT02177448

Mots-clés

  1. 08/01/2016 08/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

8 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Eligibility Hypertension NCT02177448

    Eligibility Hypertension NCT02177448

    Inclusion Criteria
    Description

    Inclusion Criteria

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

    age

    Type de données

    boolean

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

    outpatient

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    patient has secondary or malignant hypertension

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    cerebrovascular disorder

    Type de données

    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

    Type de données

    boolean

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

    renal dysfunction

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    hyperkalemia

    Type de données

    boolean

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

    enalapril

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    boolean

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

    Similar models

    Eligibility Hypertension NCT02177448

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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