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ID

17229

Description

GALLANT 5 Tesaglitazar Versus Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00214591

Lien

https://clinicaltrials.gov/show/NCT00214591

Mots-clés

Versions (1)
  1. 01/09/2016 01/09/2016 -
Téléchargé le

1 septembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Diabetes Mellitus, Type 2 NCT00214591

    Anglais

    Eligibility Diabetes Mellitus, Type 2 NCT00214591

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    provision of a written informed consent
    Description

    Informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    men or women who are ³18 years of age
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
    Description

    Gender | Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0232970
    UMLS CUI [3]
    C0020699
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0700589
    diagnosed with type 2 diabetes
    Description

    Diabetes Mellitus, Non-Insulin-Dependent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
    Description

    Diet therapy | Oral hypoglycemic Single | Oral hypoglycemic Quantity Low dose

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0012159
    UMLS CUI [2,1]
    C0359086
    UMLS CUI [2,2]
    C0205171
    UMLS CUI [3,1]
    C0359086
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C0445550
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    type 1 diabetes
    Description

    Diabetes Mellitus, Insulin-Dependent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    new york heart association heart failure class iii or iv
    Description

    New York Heart Association Classification

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1275491
    treatment with chronic insulin
    Description

    Insulin chronic

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0021641
    UMLS CUI [1,2]
    C0205191
    history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin)
    Description

    Hypersensitivity Peroxisome Proliferator-Activated Receptor agonists | Intolerance to Peroxisome Proliferator-Activated Receptor agonists | Actos | Avandia | Fenofibrate | Metformin | statin

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0166418
    UMLS CUI [1,3]
    C0243192
    UMLS CUI [2,1]
    C1744706
    UMLS CUI [2,2]
    C0166418
    UMLS CUI [2,3]
    C0243192
    UMLS CUI [3]
    C0875954
    UMLS CUI [4]
    C0875967
    UMLS CUI [5]
    C0033228
    UMLS CUI [6]
    C0025598
    UMLS CUI [7]
    C0360714
    history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
    Description

    Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Drug-induced neutropenia | White blood cell count low

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0410220
    UMLS CUI [2,1]
    C0151576
    UMLS CUI [2,2]
    C0458082
    UMLS CUI [3,1]
    C0235996
    UMLS CUI [3,2]
    C0458082
    UMLS CUI [4]
    C0272178
    UMLS CUI [5]
    C0948695
    creatinine levels above twice the normal range
    Description

    creatinine level

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0428279
    creatine kinase above 3 times the upper limit of normal
    Description

    Creatine kinase measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201973
    received any investigational product in other clinical studies within 12 weeks
    Description

    Study Subject Participation Status | Investigational New Drugs

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
    Description

    Abnormality Clinically Significant compromises patient safety | Abnormality Clinically Significant Compliance behavior Limited | Physical Examination | Laboratory Procedures | Electrocardiography

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C2945640
    UMLS CUI [1,4]
    C1113679
    UMLS CUI [2,1]
    C1704258
    UMLS CUI [2,2]
    C2985739
    UMLS CUI [2,3]
    C1321605
    UMLS CUI [2,4]
    C0439801
    UMLS CUI [3]
    C0031809
    UMLS CUI [4]
    C0022885
    UMLS CUI [5]
    C1623258
    Retour au début de la page

    Similar models

    Eligibility Diabetes Mellitus, Type 2 NCT00214591

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed consent
    Item
    provision of a written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    men or women who are ³18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Gender | Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods
    Item
    female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
    boolean
    C0079399 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    C0020699 (UMLS CUI [3])
    C3831118 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    Diabetes Mellitus, Non-Insulin-Dependent
    Item
    diagnosed with type 2 diabetes
    boolean
    C0011860 (UMLS CUI [1])
    Diet therapy | Oral hypoglycemic Single | Oral hypoglycemic Quantity Low dose
    Item
    treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
    boolean
    C0012159 (UMLS CUI [1])
    C0359086 (UMLS CUI [2,1])
    C0205171 (UMLS CUI [2,2])
    C0359086 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0445550 (UMLS CUI [3,3])
    Item Group
    C0680251 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent
    Item
    type 1 diabetes
    boolean
    C0011854 (UMLS CUI [1])
    New York Heart Association Classification
    Item
    new york heart association heart failure class iii or iv
    boolean
    C1275491 (UMLS CUI [1])
    Insulin chronic
    Item
    treatment with chronic insulin
    boolean
    C0021641 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    Hypersensitivity Peroxisome Proliferator-Activated Receptor agonists | Intolerance to Peroxisome Proliferator-Activated Receptor agonists | Actos | Avandia | Fenofibrate | Metformin | statin
    Item
    history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0166418 (UMLS CUI [1,2])
    C0243192 (UMLS CUI [1,3])
    C1744706 (UMLS CUI [2,1])
    C0166418 (UMLS CUI [2,2])
    C0243192 (UMLS CUI [2,3])
    C0875954 (UMLS CUI [3])
    C0875967 (UMLS CUI [4])
    C0033228 (UMLS CUI [5])
    C0025598 (UMLS CUI [6])
    C0360714 (UMLS CUI [7])
    Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Drug-induced neutropenia | White blood cell count low
    Item
    history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
    boolean
    C0410220 (UMLS CUI [1])
    C0151576 (UMLS CUI [2,1])
    C0458082 (UMLS CUI [2,2])
    C0235996 (UMLS CUI [3,1])
    C0458082 (UMLS CUI [3,2])
    C0272178 (UMLS CUI [4])
    C0948695 (UMLS CUI [5])
    creatinine level
    Item
    creatinine levels above twice the normal range
    boolean
    C0428279 (UMLS CUI [1])
    Creatine kinase measurement
    Item
    creatine kinase above 3 times the upper limit of normal
    boolean
    C0201973 (UMLS CUI [1])
    Study Subject Participation Status | Investigational New Drugs
    Item
    received any investigational product in other clinical studies within 12 weeks
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Abnormality Clinically Significant compromises patient safety | Abnormality Clinically Significant Compliance behavior Limited | Physical Examination | Laboratory Procedures | Electrocardiography
    Item
    any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
    boolean
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C2945640 (UMLS CUI [1,3])
    C1113679 (UMLS CUI [1,4])
    C1704258 (UMLS CUI [2,1])
    C2985739 (UMLS CUI [2,2])
    C1321605 (UMLS CUI [2,3])
    C0439801 (UMLS CUI [2,4])
    C0031809 (UMLS CUI [3])
    C0022885 (UMLS CUI [4])
    C1623258 (UMLS CUI [5])
    Retour au début de la page 

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