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ID

16470

Beskrivning

Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT02242318

Länk

https://clinicaltrials.gov/show/NCT02242318

Nyckelord

  1. 2016-07-17 2016-07-17 -
Uppladdad den

17 juli 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Hypertension NCT02242318

    Eligibility Hypertension NCT02242318

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmhg and ≤ 109 mmhg, measured by manual cuff sphygmomanometer, at visit 2
    Beskrivning

    mild-to-moderate hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3276943
    UMLS CUI [2]
    C1969581
    2. 24-hour mean dbp of ≥ 85 mmhg at visit 3 as measured by abpm
    Beskrivning

    diastolic blood pressure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428883
    3. age 18 years or older
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    4. ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
    Beskrivning

    ability to stop any current antihypertensive therapy without risk to the patient

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0585941
    5. patient's written informed consent in accordance with good clinical practice (gcp) and local legislation
    Beskrivning

    written informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
    Beskrivning

    pre-menopausal women

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0043210
    UMLS CUI [1,2]
    C0279752
    1. are not surgically sterile,
    Beskrivning

    are not surgically sterile

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021359
    2. are nursing,
    Beskrivning

    nursing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    3. are of child-bearing potential and are not practising acceptable methods of birth control, or do not plan to continue practising an acceptable method throughout the study. acceptable methods of birth control include oral, implantable or injectable contraceptives and intra uterine devices (iud)
    Beskrivning

    contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    2. known or suspected secondary hypertension
    Beskrivning

    known or suspected secondary hypertension

    Datatyp

    boolean

    3. mean sitting sbp ≥180 mmhg or mean sitting dbp ≥110 mmhg during any visit of the placebo run-in period
    Beskrivning

    sitting systolic blood pressure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1319893
    4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
    Beskrivning

    hepatic and/or renal dysfunction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C3279454
    1. serum glutamate-pyruvate-transaminase (alanine aminotransferase) (sgpt (alt)) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) (sgot (ast)) > than 2 times the upper limit of normal range,
    Beskrivning

    AST and ALT level

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    2. serum creatinine > 2.3 mg/dl (or > 203 μmol/l)
    Beskrivning

    serum creatinine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
    Beskrivning

    renal artery stenosis, postrenal transplant or with only one kidney

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0035067
    UMLS CUI [2]
    C0022671
    UMLS CUI [3]
    C0426706
    6. clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
    Beskrivning

    sodium depletion, hypokalaemia or hyperkalaemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020625
    UMLS CUI [2]
    C0020621
    UMLS CUI [3]
    C0020461
    7. uncorrected volume depletion
    Beskrivning

    uncorrected volume depletion

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0546884
    8. primary aldosteronism
    Beskrivning

    primary aldosteronism

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1719312
    9. hereditary fructose intolerance
    Beskrivning

    hereditary fructose intolerance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0016751
    10. biliary obstructive disorders
    Beskrivning

    biliary obstructive disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0400979
    11. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists
    Beskrivning

    angioedema during treatment with ace inhibitors or angiotensin II receptor antagonists

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0570450
    UMLS CUI [1,2]
    C0002994
    UMLS CUI [2,1]
    C1319923
    UMLS CUI [2,2]
    C0002994
    12. history of drug or alcohol dependency within six months prior to start of run-in period
    Beskrivning

    substance use disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    13. concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
    Beskrivning

    concomitant administration of any medications known to affect blood pressure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003364
    14. any investigational therapy within one month of signing the informed consent form
    Beskrivning

    any investigational therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1548937
    15. congestive heart failure (new york heart association (nyha) functional class congestive heart failure (chf iii-iv))
    Beskrivning

    congestive heart failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    16. unstable angina within the past three months prior to start of run-in period
    Beskrivning

    unstable angina

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0002965
    17. stroke within the past six months prior to start of run-in period
    Beskrivning

    stroke

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    18. myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
    Beskrivning

    myocardial infarction or cardiac surgery

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0018821
    19. percutaneous transluminal coronary angioplasty (ptca) within the past three months prior to start of run-in period
    Beskrivning

    ptca

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2936173
    20. sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
    Beskrivning

    arrhythmias

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003811
    21. hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
    Beskrivning

    hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007194
    UMLS CUI [2]
    C0003499
    UMLS CUI [3]
    C0003507
    UMLS CUI [4]
    C0026269
    22. patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c ≥ 10%
    Beskrivning

    uncontrolled diabetes mellitus hba1c

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0743131
    UMLS CUI [1,2]
    C0202054
    23. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (am)
    Beskrivning

    night shift workers who routinely sleep during the daytime

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0555008
    UMLS CUI [1,2]
    C4075948
    24. known hypersensitivity to any component of the formulations
    Beskrivning

    hypersensitivity to any component of the formulations

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    25. any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
    Beskrivning

    clinical condition compromising study protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C2348563
    26. inability to comply with the protocol
    Beskrivning

    inability to comply with the protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488

    Similar models

    Eligibility Hypertension NCT02242318

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    mild-to-moderate hypertension
    Item
    1. mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmhg and ≤ 109 mmhg, measured by manual cuff sphygmomanometer, at visit 2
    boolean
    C3276943 (UMLS CUI [1])
    C1969581 (UMLS CUI [2])
    diastolic blood pressure
    Item
    2. 24-hour mean dbp of ≥ 85 mmhg at visit 3 as measured by abpm
    boolean
    C0428883 (UMLS CUI [1])
    age
    Item
    3. age 18 years or older
    boolean
    C0001779 (UMLS CUI [1])
    ability to stop any current antihypertensive therapy without risk to the patient
    Item
    4. ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
    boolean
    C0585941 (UMLS CUI [1])
    written informed consent
    Item
    5. patient's written informed consent in accordance with good clinical practice (gcp) and local legislation
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pre-menopausal women
    Item
    1. pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
    boolean
    C0043210 (UMLS CUI [1,1])
    C0279752 (UMLS CUI [1,2])
    are not surgically sterile
    Item
    1. are not surgically sterile,
    boolean
    C0021359 (UMLS CUI [1])
    nursing
    Item
    2. are nursing,
    boolean
    C0006147 (UMLS CUI [1])
    contraception
    Item
    3. are of child-bearing potential and are not practising acceptable methods of birth control, or do not plan to continue practising an acceptable method throughout the study. acceptable methods of birth control include oral, implantable or injectable contraceptives and intra uterine devices (iud)
    boolean
    C0700589 (UMLS CUI [1])
    known or suspected secondary hypertension
    Item
    2. known or suspected secondary hypertension
    boolean
    sitting systolic blood pressure
    Item
    3. mean sitting sbp ≥180 mmhg or mean sitting dbp ≥110 mmhg during any visit of the placebo run-in period
    boolean
    C1319893 (UMLS CUI [1])
    hepatic and/or renal dysfunction
    Item
    4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
    boolean
    C0086565 (UMLS CUI [1])
    C3279454 (UMLS CUI [2])
    AST and ALT level
    Item
    1. serum glutamate-pyruvate-transaminase (alanine aminotransferase) (sgpt (alt)) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) (sgot (ast)) > than 2 times the upper limit of normal range,
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    serum creatinine
    Item
    2. serum creatinine > 2.3 mg/dl (or > 203 μmol/l)
    boolean
    C0201976 (UMLS CUI [1])
    renal artery stenosis, postrenal transplant or with only one kidney
    Item
    5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
    boolean
    C0035067 (UMLS CUI [1])
    C0022671 (UMLS CUI [2])
    C0426706 (UMLS CUI [3])
    sodium depletion, hypokalaemia or hyperkalaemia
    Item
    6. clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
    boolean
    C0020625 (UMLS CUI [1])
    C0020621 (UMLS CUI [2])
    C0020461 (UMLS CUI [3])
    uncorrected volume depletion
    Item
    7. uncorrected volume depletion
    boolean
    C0546884 (UMLS CUI [1])
    primary aldosteronism
    Item
    8. primary aldosteronism
    boolean
    C1719312 (UMLS CUI [1])
    hereditary fructose intolerance
    Item
    9. hereditary fructose intolerance
    boolean
    C0016751 (UMLS CUI [1])
    biliary obstructive disorders
    Item
    10. biliary obstructive disorders
    boolean
    C0400979 (UMLS CUI [1])
    angioedema during treatment with ace inhibitors or angiotensin II receptor antagonists
    Item
    11. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists
    boolean
    C0570450 (UMLS CUI [1,1])
    C0002994 (UMLS CUI [1,2])
    C1319923 (UMLS CUI [2,1])
    C0002994 (UMLS CUI [2,2])
    substance use disorder
    Item
    12. history of drug or alcohol dependency within six months prior to start of run-in period
    boolean
    C0038586 (UMLS CUI [1])
    concomitant administration of any medications known to affect blood pressure
    Item
    13. concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
    boolean
    C0003364 (UMLS CUI [1])
    any investigational therapy
    Item
    14. any investigational therapy within one month of signing the informed consent form
    boolean
    C1548937 (UMLS CUI [1])
    congestive heart failure
    Item
    15. congestive heart failure (new york heart association (nyha) functional class congestive heart failure (chf iii-iv))
    boolean
    C0018802 (UMLS CUI [1])
    unstable angina
    Item
    16. unstable angina within the past three months prior to start of run-in period
    boolean
    C0002965 (UMLS CUI [1])
    stroke
    Item
    17. stroke within the past six months prior to start of run-in period
    boolean
    C0038454 (UMLS CUI [1])
    myocardial infarction or cardiac surgery
    Item
    18. myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
    boolean
    C0027051 (UMLS CUI [1])
    C0018821 (UMLS CUI [2])
    ptca
    Item
    19. percutaneous transluminal coronary angioplasty (ptca) within the past three months prior to start of run-in period
    boolean
    C2936173 (UMLS CUI [1])
    arrhythmias
    Item
    20. sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
    boolean
    C0003811 (UMLS CUI [1])
    hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
    Item
    21. hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
    boolean
    C0007194 (UMLS CUI [1])
    C0003499 (UMLS CUI [2])
    C0003507 (UMLS CUI [3])
    C0026269 (UMLS CUI [4])
    uncontrolled diabetes mellitus hba1c
    Item
    22. patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c ≥ 10%
    boolean
    C0743131 (UMLS CUI [1,1])
    C0202054 (UMLS CUI [1,2])
    night shift workers who routinely sleep during the daytime
    Item
    23. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (am)
    boolean
    C0555008 (UMLS CUI [1,1])
    C4075948 (UMLS CUI [1,2])
    hypersensitivity to any component of the formulations
    Item
    24. known hypersensitivity to any component of the formulations
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    clinical condition compromising study protocol
    Item
    25. any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C2348563 (UMLS CUI [1,3])
    inability to comply with the protocol
    Item
    26. inability to comply with the protocol
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])

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