0 Ratings
ID

43520

Description

ODM derived from http://clinicaltrials.gov/show/NCT00974740

Link

http://clinicaltrials.gov/show/NCT00974740

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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Creative Commons BY 4.0
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    Eligibility NCT00974740 Type 1 Diabetes

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age 18 Years to 39 Years
    Description

    age 18 Years to 39 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
    Description

    Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0455628
    SNOMED CT 2011_0131
    161649006
    UMLS CUI 2011AA
    C1518321
    UMLS CUI 2011AA
    C0011854
    SNOMED CT 2011_0131
    46635009
    MedDRA 14.1
    10067584
    LOINC Version 232
    MTHU020217
    ICD-10-CM Version 2010
    E10
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C1705019
    UMLS CUI 2011AA
    CL414621
    Male patient or female patient using adequate contraceptive methods
    Description

    Male patient or female patient using adequate contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
    Description

    Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1335447
    UMLS CUI 2011AA
    C0011849
    SNOMED CT 2011_0131
    191044006
    UMLS CUI 2011AA
    C0699792
    SNOMED CT 2011_0131
    263498003
    UMLS CUI 2011AA
    C0004358
    SNOMED CT 2011_0131
    30621004
    LOINC Version 232
    MTHU031562
    UMLS CUI 2011AA
    C1414926
    UMLS CUI 2011AA
    C1419119
    UMLS CUI 2011AA
    C0201519
    SNOMED CT 2011_0131
    64135003
    MedDRA 14.1
    10050516
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    History of neoplastic disease
    Description

    History of a malignancy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0006826
    Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal
    Description

    Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023895
    SNOMED CT 2011_0131
    235856003
    MedDRA 14.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    UMLS CUI 2011AA
    C0022658
    SNOMED CT 2011_0131
    90708001
    MedDRA 14.1
    10029151
    ICD-10-CM Version 2010
    N18.9
    UMLS CUI 2011AA
    CL414623
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    UMLS CUI 2011AA
    C0004002
    SNOMED CT 2011_0131
    26091008
    LOINC Version 232
    MTHU004883
    UMLS CUI 2011AA
    C0001899
    SNOMED CT 2011_0131
    56935002
    LOINC Version 232
    MTHU006766
    UMLS CUI 2011AA
    C1519815
    Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
    Description

    Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0348080
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    UMLS CUI 2011AA
    C0392760
    SNOMED CT 2011_0131
    247591002
    UMLS CUI 2011AA
    C0521982
    SNOMED CT 2011_0131
    182985004
    UMLS CUI 2011AA
    C0332281
    SNOMED CT 2011_0131
    47429007
    UMLS CUI 2011AA
    C0205217
    HL7 V3 2006_05
    U
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0035647
    SNOMED CT 2011_0131
    30207005
    HL7 V3 2006_05
    RSK
    Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
    Description

    Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0003211
    SNOMED CT 2011_0131
    16403005, 372665008
    UMLS CUI 2011AA
    C0005525
    UMLS CUI 2011AA
    C0003364
    SNOMED CT 2011_0131
    372586001
    UMLS CUI 2011AA
    C0086440
    SNOMED CT 2011_0131
    57952007
    UMLS CUI 2011AA
    C0935929
    SNOMED CT 2011_0131
    373245004
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C0021641
    SNOMED CT 2011_0131
    67866001
    LOINC Version 232
    MTHU019392
    Pregnant or nursing women or women intending to become pregnant
    Description

    Pregnant or nursing women or women intending to become pregnant

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    UMLS CUI 2011AA
    C0032992
    SNOMED CT 2011_0131
    169565003
    Known or suspected allergy to atorvastatin or any component of the trial product
    Description

    Known or suspected allergy to atorvastatin or any component of the trial product

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    257550005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0286651
    SNOMED CT 2011_0131
    373444002
    UMLS CUI 2011AA
    C1705248
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal
    Description

    Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0026848
    SNOMED CT 2011_0131
    129565002
    MedDRA 14.1
    10028641
    ICD-10-CM Version 2010
    G72.9
    ICD-9-CM Version 2011
    359.9
    UMLS CUI 2011AA
    C0231528
    SNOMED CT 2011_0131
    68962001
    MedDRA 14.1
    10028323
    LOINC Version 232
    MTHU013523
    ICD-10-CM Version 2010
    M79.1
    CTCAE 1105E
    E12485
    UMLS CUI 2011AA
    C0027121
    SNOMED CT 2011_0131
    26889001
    MedDRA 14.1
    10028653
    ICD-10-CM Version 2010
    M60.9
    CTCAE 1105E
    E12489
    UMLS CUI 2011AA
    C0750860
    MedDRA 14.1
    10040222
    UMLS CUI 2011AA
    C1519815
    Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
    Description

    Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    CL353706
    UMLS CUI 2011AA
    C0005794
    SNOMED CT 2011_0131
    25179006
    Any significant laboratory abnormality
    Description

    Any significant laboratory abnormality

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0750502
    SNOMED CT 2011_0131
    386134007
    UMLS CUI 2011AA
    C0438215
    SNOMED CT 2011_0131
    165346000
    MedDRA 14.1
    10023547
    A serum LDL-cholesterol > 150 mg/dL at time of screening
    Description

    A serum LDL-cholesterol > 150 mg/dL at time of screening

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0428474
    SNOMED CT 2011_0131
    166833005
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C1409616
    Unwillingness to comply with study procedures
    Description

    Unwillingness to comply with study procedures

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0558080
    SNOMED CT 2011_0131
    225465005
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0680734
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age 18 Years to 39 Years
    Item
    age 18 Years to 39 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
    Item
    Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
    boolean
    C0455628 (UMLS CUI 2011AA)
    161649006 (SNOMED CT 2011_0131)
    C1518321 (UMLS CUI 2011AA)
    C0011854 (UMLS CUI 2011AA)
    46635009 (SNOMED CT 2011_0131)
    10067584 (MedDRA 14.1)
    MTHU020217 (LOINC Version 232)
    E10 (ICD-10-CM Version 2010)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C1704788 (UMLS CUI 2011AA)
    C1705019 (UMLS CUI 2011AA)
    CL414621 (UMLS CUI 2011AA)
    Male patient or female patient using adequate contraceptive methods
    Item
    Male patient or female patient using adequate contraceptive methods
    boolean
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0205411 (UMLS CUI 2011AA)
    88323005 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
    Item
    Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
    boolean
    C1335447 (UMLS CUI 2011AA)
    C0011849 (UMLS CUI 2011AA)
    191044006 (SNOMED CT 2011_0131)
    C0699792 (UMLS CUI 2011AA)
    263498003 (SNOMED CT 2011_0131)
    C0004358 (UMLS CUI 2011AA)
    30621004 (SNOMED CT 2011_0131)
    MTHU031562 (LOINC Version 232)
    C1414926 (UMLS CUI 2011AA)
    C1419119 (UMLS CUI 2011AA)
    C0201519 (UMLS CUI 2011AA)
    64135003 (SNOMED CT 2011_0131)
    10050516 (MedDRA 14.1)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    History of a malignancy
    Item
    History of neoplastic disease
    boolean
    C0006826 (UMLS CUI 2011AA)
    Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal
    Item
    Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal
    boolean
    C0023895 (UMLS CUI 2011AA)
    235856003 (SNOMED CT 2011_0131)
    10024670 (MedDRA 14.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    C0022658 (UMLS CUI 2011AA)
    90708001 (SNOMED CT 2011_0131)
    10029151 (MedDRA 14.1)
    N18.9 (ICD-10-CM Version 2010)
    CL414623 (UMLS CUI 2011AA)
    C0201976 (UMLS CUI 2011AA)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    C0004002 (UMLS CUI 2011AA)
    26091008 (SNOMED CT 2011_0131)
    MTHU004883 (LOINC Version 232)
    C0001899 (UMLS CUI 2011AA)
    56935002 (SNOMED CT 2011_0131)
    MTHU006766 (LOINC Version 232)
    C1519815 (UMLS CUI 2011AA)
    Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
    Item
    Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
    boolean
    C0348080 (UMLS CUI 2011AA)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    C0392760 (UMLS CUI 2011AA)
    247591002 (SNOMED CT 2011_0131)
    C0521982 (UMLS CUI 2011AA)
    182985004 (SNOMED CT 2011_0131)
    C0332281 (UMLS CUI 2011AA)
    47429007 (SNOMED CT 2011_0131)
    C0205217 (UMLS CUI 2011AA)
    U (HL7 V3 2006_05)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0035647 (UMLS CUI 2011AA)
    30207005 (SNOMED CT 2011_0131)
    RSK (HL7 V3 2006_05)
    Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
    Item
    Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
    boolean
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0003211 (UMLS CUI 2011AA)
    16403005, 372665008 (SNOMED CT 2011_0131)
    C0005525 (UMLS CUI 2011AA)
    C0003364 (UMLS CUI 2011AA)
    372586001 (SNOMED CT 2011_0131)
    C0086440 (UMLS CUI 2011AA)
    57952007 (SNOMED CT 2011_0131)
    C0935929 (UMLS CUI 2011AA)
    373245004 (SNOMED CT 2011_0131)
    CL411789 (UMLS CUI 2011AA)
    C0021641 (UMLS CUI 2011AA)
    67866001 (SNOMED CT 2011_0131)
    MTHU019392 (LOINC Version 232)
    Pregnant or nursing women or women intending to become pregnant
    Item
    Pregnant or nursing women or women intending to become pregnant
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    C0032992 (UMLS CUI 2011AA)
    169565003 (SNOMED CT 2011_0131)
    Known or suspected allergy to atorvastatin or any component of the trial product
    Item
    Known or suspected allergy to atorvastatin or any component of the trial product
    boolean
    C0020517 (UMLS CUI 2011AA)
    257550005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0286651 (UMLS CUI 2011AA)
    373444002 (SNOMED CT 2011_0131)
    C1705248 (UMLS CUI 2011AA)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal
    Item
    Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal
    boolean
    C0026848 (UMLS CUI 2011AA)
    129565002 (SNOMED CT 2011_0131)
    10028641 (MedDRA 14.1)
    G72.9 (ICD-10-CM Version 2010)
    359.9 (ICD-9-CM Version 2011)
    C0231528 (UMLS CUI 2011AA)
    68962001 (SNOMED CT 2011_0131)
    10028323 (MedDRA 14.1)
    MTHU013523 (LOINC Version 232)
    M79.1 (ICD-10-CM Version 2010)
    E12485 (CTCAE 1105E)
    C0027121 (UMLS CUI 2011AA)
    26889001 (SNOMED CT 2011_0131)
    10028653 (MedDRA 14.1)
    M60.9 (ICD-10-CM Version 2010)
    E12489 (CTCAE 1105E)
    C0750860 (UMLS CUI 2011AA)
    10040222 (MedDRA 14.1)
    C1519815 (UMLS CUI 2011AA)
    Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
    Item
    Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
    boolean
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    CL353706 (UMLS CUI 2011AA)
    C0005794 (UMLS CUI 2011AA)
    25179006 (SNOMED CT 2011_0131)
    Any significant laboratory abnormality
    Item
    Any significant laboratory abnormality
    boolean
    C0750502 (UMLS CUI 2011AA)
    386134007 (SNOMED CT 2011_0131)
    C0438215 (UMLS CUI 2011AA)
    165346000 (SNOMED CT 2011_0131)
    10023547 (MedDRA 14.1)
    A serum LDL-cholesterol > 150 mg/dL at time of screening
    Item
    A serum LDL-cholesterol > 150 mg/dL at time of screening
    boolean
    C0428474 (UMLS CUI 2011AA)
    166833005 (SNOMED CT 2011_0131)
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    Unwillingness to comply with study procedures
    Item
    Unwillingness to comply with study procedures
    boolean
    C0558080 (UMLS CUI 2011AA)
    225465005 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0680734 (UMLS CUI 2011AA)
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