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ID

17663

Beschreibung

An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00185068

Link

https://clinicaltrials.gov/show/NCT00185068

Stichworte

  1. 27.09.16 27.09.16 -
Hochgeladen am

27. September 2016

DOI

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Creative Commons BY 4.0

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    Eligibility Hypertension NCT00185068

    Eligibility Hypertension NCT00185068

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. 18 years of age.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. patients with stage ii systolic hypertension
    Beschreibung

    Systolic hypertension disease stage

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221155
    UMLS CUI [1,2]
    C0699749
    3. if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
    Beschreibung

    Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods | Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0430061
    UMLS CUI [2]
    C0232970
    UMLS CUI [3]
    C0020699
    UMLS CUI [4]
    C0520483
    UMLS CUI [5,1]
    C3831118
    UMLS CUI [5,2]
    C0700589
    UMLS CUI [6]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. hypertensive encephalopathy, stroke or transient ischemic attack (tia) within the past 6 months.
    Beschreibung

    Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151620
    UMLS CUI [2]
    C0038454
    UMLS CUI [3]
    C0007787
    2. history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2,1]
    C0877341
    UMLS CUI [2,2]
    C0522520
    UMLS CUI [2,3]
    C0522523
    UMLS CUI [3]
    C0010055
    UMLS CUI [4]
    C0002965
    3. severe hypertension (dbp greater than or equal to 110 mm hg or sbp > 200 mm hg).
    Beschreibung

    Hypertension, severe | Diastolic blood pressure | Systolic Pressure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4013784
    UMLS CUI [2]
    C0428883
    UMLS CUI [3]
    C0871470
    4. history of secondary hypertension including renal disease, phaeochromocytoma, or cushing's disease.
    Beschreibung

    Secondary hypertension | Kidney Diseases | Pheochromocytoma | Cushing's disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0155616
    UMLS CUI [2]
    C0022658
    UMLS CUI [3]
    C0031511
    UMLS CUI [4]
    C0221406
    5. type i diabetes mellitus. 6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
    Beschreibung

    Diabetes Mellitus, Insulin-Dependent | Resting Bradycardia Symptomatic Evidence of | Congestive heart failure | Heart valve disease Hemodynamic Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    UMLS CUI [2,1]
    C3278174
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [2,3]
    C0332120
    UMLS CUI [3]
    C0018802
    UMLS CUI [4,1]
    C0018824
    UMLS CUI [4,2]
    C0019010
    UMLS CUI [4,3]
    C0750502
    7. presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter.
    Beschreibung

    Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018794
    UMLS CUI [2]
    C3854673
    UMLS CUI [3]
    C0043202
    UMLS CUI [4]
    C0037052
    UMLS CUI [5]
    C0004238
    UMLS CUI [6]
    C0004239
    8. laboratory test values considered clinically significant by the investigator.
    Beschreibung

    Laboratory Results Clinical Significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C2826293
    9. evidence of liver disease as indicated by sgot or sgpt and/or total bilirubin > 3 times the upper limit of normal.
    Beschreibung

    Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C1278039
    10. pregnant or lactating females.
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    11. patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
    Beschreibung

    Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0553723
    UMLS CUI [3]
    C0007117

    Ähnliche Modelle

    Eligibility Hypertension NCT00185068

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Systolic hypertension disease stage
    Item
    2. patients with stage ii systolic hypertension
    boolean
    C0221155 (UMLS CUI [1,1])
    C0699749 (UMLS CUI [1,2])
    Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods | Informed Consent
    Item
    3. if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0430061 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    C0020699 (UMLS CUI [3])
    C0520483 (UMLS CUI [4])
    C3831118 (UMLS CUI [5,1])
    C0700589 (UMLS CUI [5,2])
    C0021430 (UMLS CUI [6])
    Item Group
    C0680251 (UMLS CUI)
    Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack
    Item
    1. hypertensive encephalopathy, stroke or transient ischemic attack (tia) within the past 6 months.
    boolean
    C0151620 (UMLS CUI [1])
    C0038454 (UMLS CUI [2])
    C0007787 (UMLS CUI [3])
    Myocardial Infarction | Coronary revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable
    Item
    2. history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
    boolean
    C0027051 (UMLS CUI [1])
    C0877341 (UMLS CUI [2,1])
    C0522520 (UMLS CUI [2,2])
    C0522523 (UMLS CUI [2,3])
    C0010055 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    Hypertension, severe | Diastolic blood pressure | Systolic Pressure
    Item
    3. severe hypertension (dbp greater than or equal to 110 mm hg or sbp > 200 mm hg).
    boolean
    C4013784 (UMLS CUI [1])
    C0428883 (UMLS CUI [2])
    C0871470 (UMLS CUI [3])
    Secondary hypertension | Kidney Diseases | Pheochromocytoma | Cushing's disease
    Item
    4. history of secondary hypertension including renal disease, phaeochromocytoma, or cushing's disease.
    boolean
    C0155616 (UMLS CUI [1])
    C0022658 (UMLS CUI [2])
    C0031511 (UMLS CUI [3])
    C0221406 (UMLS CUI [4])
    Diabetes Mellitus, Insulin-Dependent | Resting Bradycardia Symptomatic Evidence of | Congestive heart failure | Heart valve disease Hemodynamic Significant
    Item
    5. type i diabetes mellitus. 6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
    boolean
    C0011854 (UMLS CUI [1])
    C3278174 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C0332120 (UMLS CUI [2,3])
    C0018802 (UMLS CUI [3])
    C0018824 (UMLS CUI [4,1])
    C0019010 (UMLS CUI [4,2])
    C0750502 (UMLS CUI [4,3])
    Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter
    Item
    7. presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter.
    boolean
    C0018794 (UMLS CUI [1])
    C3854673 (UMLS CUI [2])
    C0043202 (UMLS CUI [3])
    C0037052 (UMLS CUI [4])
    C0004238 (UMLS CUI [5])
    C0004239 (UMLS CUI [6])
    Laboratory Results Clinical Significance
    Item
    8. laboratory test values considered clinically significant by the investigator.
    boolean
    C1254595 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
    Item
    9. evidence of liver disease as indicated by sgot or sgpt and/or total bilirubin > 3 times the upper limit of normal.
    boolean
    C0023895 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    Pregnancy | Breast Feeding
    Item
    10. pregnant or lactating females.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma
    Item
    11. patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
    boolean
    C0006826 (UMLS CUI [1])
    C0553723 (UMLS CUI [2])
    C0007117 (UMLS CUI [3])

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