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ID

17658

Description

Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00170950

Lien

https://clinicaltrials.gov/show/NCT00170950

Mots-clés

Versions (2)
  1. 27/09/2016 27/09/2016 -
  2. 27/09/2016 27/09/2016 -
Téléchargé le

27 septembre 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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    Eligibility Hypertension NCT00170950

    Anglais

    Eligibility Hypertension NCT00170950

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    at least 55 years of age.
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    previously untreated or treated hypertension.
    Description

    hypertension untreated | Hypertensive disease Treated

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0745134
    UMLS CUI [2,1]
    C0020538
    UMLS CUI [2,2]
    C1522326
    for patients >= 60 years, evidence of at least one cv disease or target organ damage, or for patients 55-59 years evidence of at least two cv diseases or target organ damage from two different organ systems as defined in the protocol.
    Description

    Age | Cardiovascular Diseases Quantity Evidence of | Target Organ Damage | Target Organ Damage Related body system Different

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0007222
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0332120
    UMLS CUI [3,1]
    C1521840
    UMLS CUI [3,2]
    C0178784
    UMLS CUI [3,3]
    C1883709
    UMLS CUI [4,1]
    C1521840
    UMLS CUI [4,2]
    C0178784
    UMLS CUI [4,3]
    C1883709
    UMLS CUI [4,4]
    C0439849
    UMLS CUI [4,5]
    C0460002
    UMLS CUI [4,6]
    C1705242
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    allergy to any of the drugs administered in this trial.
    Description

    Hypersensitivity Investigational New Drugs

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    current angina pectoris (ie, no anginal event requiring ntg within 1 month prior to visit 1).
    Description

    Angina Pectoris | Angina Pectoris Event Requirement Nitroglycerin

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0002962
    UMLS CUI [2,1]
    C0002962
    UMLS CUI [2,2]
    C0441471
    UMLS CUI [2,3]
    C1514873
    UMLS CUI [2,4]
    C0017887
    secondary hypertension.
    Description

    Secondary hypertension

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0155616
    refractory hypertension defined as sbp >= 180 mmhg and/or dbp >= 110 mmhg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
    Description

    Refractory hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Treatment | Sympatholytics | Diuretics | Vasodilator Agents

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0860493
    UMLS CUI [2]
    C0871470
    UMLS CUI [3]
    C0428883
    UMLS CUI [4]
    C0205269
    UMLS CUI [5]
    C0039051
    UMLS CUI [6]
    C0012798
    UMLS CUI [7]
    C0042402
    history of symptomatic heart failure (nyha classes ii-iv) or ejection fraction < 40%.
    Description

    Heart failure Symptomatic | New York Heart Association Classification | Cardiac ejection fraction

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2]
    C1275491
    UMLS CUI [3]
    C0232174
    myocardial infarction, coronary revascularization (cabg or pci), unstable angina within one month of visit 1.
    Description

    Myocardial Infarction | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0877341
    UMLS CUI [3]
    C0010055
    UMLS CUI [4]
    C1532338
    UMLS CUI [5]
    C0002965
    stroke or transient ischemic event (tia) within 3 months of visit 1.
    Description

    Cerebrovascular accident | Transient Ischemic Attack

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    UMLS CUI [2]
    C0007787
    significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
    Description

    disease; valve, valvular (obstructive) Significant | Cardiovascular Disease Significant | Valvular disease Resulting in Operative Surgical Procedures

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1384985
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2,1]
    C0007222
    UMLS CUI [2,2]
    C0750502
    UMLS CUI [3,1]
    C3258293
    UMLS CUI [3,2]
    C0332294
    UMLS CUI [3,3]
    C0543467
    evidence of hepatic disease (ast or alt values >= 2 x upper limit of normal).
    Description

    Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0201836
    impaired renal function (serum creatinine >= 2.5 mg/dl (221 µmol/l)).
    Description

    Renal Insufficiency | Creatinine measurement, serum

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0201976
    baseline serum potassium of > 5.2 meq/l not on potassium supplements.
    Description

    Serum potassium measurement | Potassium supplement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0302353
    UMLS CUI [2]
    C0304475
    history of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
    Description

    Malignant Neoplasms | leukemia | Lymphoma | Basal cell carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0023418
    UMLS CUI [3]
    C0024299
    UMLS CUI [4]
    C0007117
    history of clinically significant auto immune disorders such as systemic lupus erythematosus.
    Description

    Autoimmune Diseases Clinical Significance | Lupus Erythematosus, Systemic

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2]
    C0024141
    significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy <5 years).
    Description

    Illness Significant Resulting in Cessation of life Probably | Organ Transplantation Major | Life Expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [1,3]
    C0332294
    UMLS CUI [1,4]
    C0011065
    UMLS CUI [1,5]
    C0750492
    UMLS CUI [2,1]
    C0029216
    UMLS CUI [2,2]
    C0205164
    UMLS CUI [3]
    C0023671
    significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.
    Description

    Cardiovascular Disease Significant | Aortic Aneurysm Requirement Probably Operative Surgical Procedures

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2,1]
    C0003486
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0750492
    UMLS CUI [2,4]
    C0543467
    other protocol-defined exclusion criteria applied to the study.
    Description

    Exclusion Criteria Study Protocol

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C2348563
    Retour au début de la page

    Similar models

    Eligibility Hypertension NCT00170950

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    at least 55 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    hypertension untreated | Hypertensive disease Treated
    Item
    previously untreated or treated hypertension.
    boolean
    C0745134 (UMLS CUI [1])
    C0020538 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    Age | Cardiovascular Diseases Quantity Evidence of | Target Organ Damage | Target Organ Damage Related body system Different
    Item
    for patients >= 60 years, evidence of at least one cv disease or target organ damage, or for patients 55-59 years evidence of at least two cv diseases or target organ damage from two different organ systems as defined in the protocol.
    boolean
    C0001779 (UMLS CUI [1])
    C0007222 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0332120 (UMLS CUI [2,3])
    C1521840 (UMLS CUI [3,1])
    C0178784 (UMLS CUI [3,2])
    C1883709 (UMLS CUI [3,3])
    C1521840 (UMLS CUI [4,1])
    C0178784 (UMLS CUI [4,2])
    C1883709 (UMLS CUI [4,3])
    C0439849 (UMLS CUI [4,4])
    C0460002 (UMLS CUI [4,5])
    C1705242 (UMLS CUI [4,6])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Investigational New Drugs
    Item
    allergy to any of the drugs administered in this trial.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Angina Pectoris | Angina Pectoris Event Requirement Nitroglycerin
    Item
    current angina pectoris (ie, no anginal event requiring ntg within 1 month prior to visit 1).
    boolean
    C0002962 (UMLS CUI [1])
    C0002962 (UMLS CUI [2,1])
    C0441471 (UMLS CUI [2,2])
    C1514873 (UMLS CUI [2,3])
    C0017887 (UMLS CUI [2,4])
    Secondary hypertension
    Item
    secondary hypertension.
    boolean
    C0155616 (UMLS CUI [1])
    Refractory hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Treatment | Sympatholytics | Diuretics | Vasodilator Agents
    Item
    refractory hypertension defined as sbp >= 180 mmhg and/or dbp >= 110 mmhg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
    boolean
    C0860493 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0428883 (UMLS CUI [3])
    C0205269 (UMLS CUI [4])
    C0039051 (UMLS CUI [5])
    C0012798 (UMLS CUI [6])
    C0042402 (UMLS CUI [7])
    Heart failure Symptomatic | New York Heart Association Classification | Cardiac ejection fraction
    Item
    history of symptomatic heart failure (nyha classes ii-iv) or ejection fraction < 40%.
    boolean
    C0018801 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [2])
    C0232174 (UMLS CUI [3])
    Myocardial Infarction | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable
    Item
    myocardial infarction, coronary revascularization (cabg or pci), unstable angina within one month of visit 1.
    boolean
    C0027051 (UMLS CUI [1])
    C0877341 (UMLS CUI [2])
    C0010055 (UMLS CUI [3])
    C1532338 (UMLS CUI [4])
    C0002965 (UMLS CUI [5])
    Cerebrovascular accident | Transient Ischemic Attack
    Item
    stroke or transient ischemic event (tia) within 3 months of visit 1.
    boolean
    C0038454 (UMLS CUI [1])
    C0007787 (UMLS CUI [2])
    disease; valve, valvular (obstructive) Significant | Cardiovascular Disease Significant | Valvular disease Resulting in Operative Surgical Procedures
    Item
    significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
    boolean
    C1384985 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0007222 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    C3258293 (UMLS CUI [3,1])
    C0332294 (UMLS CUI [3,2])
    C0543467 (UMLS CUI [3,3])
    Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    evidence of hepatic disease (ast or alt values >= 2 x upper limit of normal).
    boolean
    C0023895 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    Renal Insufficiency | Creatinine measurement, serum
    Item
    impaired renal function (serum creatinine >= 2.5 mg/dl (221 µmol/l)).
    boolean
    C1565489 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Serum potassium measurement | Potassium supplement
    Item
    baseline serum potassium of > 5.2 meq/l not on potassium supplements.
    boolean
    C0302353 (UMLS CUI [1])
    C0304475 (UMLS CUI [2])
    Malignant Neoplasms | leukemia | Lymphoma | Basal cell carcinoma
    Item
    history of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
    boolean
    C0006826 (UMLS CUI [1])
    C0023418 (UMLS CUI [2])
    C0024299 (UMLS CUI [3])
    C0007117 (UMLS CUI [4])
    Autoimmune Diseases Clinical Significance | Lupus Erythematosus, Systemic
    Item
    history of clinically significant auto immune disorders such as systemic lupus erythematosus.
    boolean
    C0004364 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0024141 (UMLS CUI [2])
    Illness Significant Resulting in Cessation of life Probably | Organ Transplantation Major | Life Expectancy
    Item
    significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy <5 years).
    boolean
    C0221423 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0332294 (UMLS CUI [1,3])
    C0011065 (UMLS CUI [1,4])
    C0750492 (UMLS CUI [1,5])
    C0029216 (UMLS CUI [2,1])
    C0205164 (UMLS CUI [2,2])
    C0023671 (UMLS CUI [3])
    Cardiovascular Disease Significant | Aortic Aneurysm Requirement Probably Operative Surgical Procedures
    Item
    significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.
    boolean
    C0007222 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0003486 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0750492 (UMLS CUI [2,3])
    C0543467 (UMLS CUI [2,4])
    Exclusion Criteria Study Protocol
    Item
    other protocol-defined exclusion criteria applied to the study.
    boolean
    C0680251 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Retour au début de la page 

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