0 Bedömningar
ID

44244

Beskrivning

Olmesartan on Ambulatory Blood Pressure Change; ODM derived from: https://clinicaltrials.gov/show/NCT00854763

Länk

https://clinicaltrials.gov/show/NCT00854763

Nyckelord

Versioner (2)
  1. 2018-05-02 2018-05-02 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Hypertension NCT00854763

    Engelsk

    Eligibility Hypertension NCT00854763

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male or female, 18 years of age or over.
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    naïve patients with stage i** or stage ii** (jnc vii) essential hypertension or patients uncontrolled on current hypotensive drug therapy (in cuff bp>140/90mm hg)
    Beskrivning

    Therapy naive Essential Hypertension Stage | Antihypertensive therapy Absent | Blood pressure measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0919936
    UMLS CUI [1,2]
    C0085580
    UMLS CUI [1,3]
    C0699749
    UMLS CUI [2,1]
    C0585941
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3]
    C0005824
    all selected patients must give their written informed consent before recording their personal data
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subject with secondary form of hypertension
    Beskrivning

    Secondary hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0155616
    subject is being treated or with unstable condition for disease of myocardial infarction, clinically decompensated congestive heart failure, angina pectoris, sick sinus syndrome, second or third degree atrioventricular block
    Beskrivning

    Myocardial Infarction Treated | DECOMPENSATED CONGESTIVE HEART FAILURE Treated | Angina Pectoris Treated | Sick Sinus Syndrome Treated | Second degree atrioventricular block Treated | Complete atrioventricular block Treated | Myocardial Infarction Unstable | DECOMPENSATED CONGESTIVE HEART FAILURE Unstable | Angina, Unstable | Sick Sinus Syndrome Unstable | Second degree atrioventricular block Unstable | Complete atrioventricular block Unstable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C1522326
    UMLS CUI [2,1]
    C0742746
    UMLS CUI [2,2]
    C1522326
    UMLS CUI [3,1]
    C0002962
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [4,1]
    C0037052
    UMLS CUI [4,2]
    C1522326
    UMLS CUI [5,1]
    C0264906
    UMLS CUI [5,2]
    C1522326
    UMLS CUI [6,1]
    C0151517
    UMLS CUI [6,2]
    C1522326
    UMLS CUI [7,1]
    C0027051
    UMLS CUI [7,2]
    C0443343
    UMLS CUI [8,1]
    C0742746
    UMLS CUI [8,2]
    C0443343
    UMLS CUI [9]
    C0002965
    UMLS CUI [10,1]
    C0037052
    UMLS CUI [10,2]
    C0443343
    UMLS CUI [11,1]
    C0264906
    UMLS CUI [11,2]
    C0443343
    UMLS CUI [12,1]
    C0151517
    UMLS CUI [12,2]
    C0443343
    subject with history of hypertensive encephalopathy, grade 3 or 4 hypertensive retinopathy within 3 months before entering this trial
    Beskrivning

    Hypertensive Encephalopathy | Hypertensive Retinopathy Grade

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0151620
    UMLS CUI [2,1]
    C0152132
    UMLS CUI [2,2]
    C0441800
    subjects with a cerebrovascular accident within 6 months before entering this trial
    Beskrivning

    Cerebrovascular accident

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    subject with auto-immune disease
    Beskrivning

    Autoimmune Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    subject with uncontrolled endocrine diseases, such as hyperthyroidism, hypothyroidism, hypercorticism and hypocorticism
    Beskrivning

    Endocrine System Diseases Uncontrolled | Hyperthyroidism | Hypothyroidism | Adrenal Gland Hyperfunction | Adrenal gland hypofunction

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0014130
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0020550
    UMLS CUI [3]
    C0020676
    UMLS CUI [4]
    C0001622
    UMLS CUI [5]
    C0001623
    subject with confirmed evidence of renal impairment (creatinine > 1.5 x upper limit of normal)
    Beskrivning

    Renal Insufficiency | Serum creatinine raised

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0700225
    subject with hyperkalemia with serum potassium > 5.5 meq/l
    Beskrivning

    Hyperkalemia | Serum potassium measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020461
    UMLS CUI [2]
    C0302353
    subject with terminal stage of malignant disease
    Beskrivning

    Malignant disease End-stage

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0442867
    UMLS CUI [1,2]
    C0205088
    subject with substance abuse history
    Beskrivning

    Substance Use Disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    subject with gastrointestinal disease which can interfere the absorption of the oral medications
    Beskrivning

    Gastrointestinal Disease Interferes with Absorption Oral medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0017178
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0237442
    UMLS CUI [1,4]
    C0175795
    subject with any contraindication to the use of angiotensin ii receptor blocker or calcium channel blocker
    Beskrivning

    Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0521942
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0006684
    subject is pregnant or lactating
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    premenopausal subjects not taking reliable methods for contraceptives
    Beskrivning

    Premenopausal state Contraceptive methods Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232969
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C0332197
    subject with any other serious disease considered by the investigator not in the condition to enter the trial
    Beskrivning

    Disease Serious | Study Subject Participation Status Excluded

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0332196
    subject is not able to comply to the protocol requirements
    Beskrivning

    Protocol Compliance Unable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    subject participated investigational drug trial within 3 months before entering this study
    Beskrivning

    Study Subject Participation Status | Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
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    Similar models

    Eligibility Hypertension NCT00854763

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    male or female, 18 years of age or over.
    boolean
    C0001779 (UMLS CUI [1])
    Therapy naive Essential Hypertension Stage | Antihypertensive therapy Absent | Blood pressure measurement
    Item
    naïve patients with stage i** or stage ii** (jnc vii) essential hypertension or patients uncontrolled on current hypotensive drug therapy (in cuff bp>140/90mm hg)
    boolean
    C0919936 (UMLS CUI [1,1])
    C0085580 (UMLS CUI [1,2])
    C0699749 (UMLS CUI [1,3])
    C0585941 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0005824 (UMLS CUI [3])
    Informed Consent
    Item
    all selected patients must give their written informed consent before recording their personal data
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Secondary hypertension
    Item
    subject with secondary form of hypertension
    boolean
    C0155616 (UMLS CUI [1])
    Myocardial Infarction Treated | DECOMPENSATED CONGESTIVE HEART FAILURE Treated | Angina Pectoris Treated | Sick Sinus Syndrome Treated | Second degree atrioventricular block Treated | Complete atrioventricular block Treated | Myocardial Infarction Unstable | DECOMPENSATED CONGESTIVE HEART FAILURE Unstable | Angina, Unstable | Sick Sinus Syndrome Unstable | Second degree atrioventricular block Unstable | Complete atrioventricular block Unstable
    Item
    subject is being treated or with unstable condition for disease of myocardial infarction, clinically decompensated congestive heart failure, angina pectoris, sick sinus syndrome, second or third degree atrioventricular block
    boolean
    C0027051 (UMLS CUI [1,1])
    C1522326 (UMLS CUI [1,2])
    C0742746 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    C0002962 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0037052 (UMLS CUI [4,1])
    C1522326 (UMLS CUI [4,2])
    C0264906 (UMLS CUI [5,1])
    C1522326 (UMLS CUI [5,2])
    C0151517 (UMLS CUI [6,1])
    C1522326 (UMLS CUI [6,2])
    C0027051 (UMLS CUI [7,1])
    C0443343 (UMLS CUI [7,2])
    C0742746 (UMLS CUI [8,1])
    C0443343 (UMLS CUI [8,2])
    C0002965 (UMLS CUI [9])
    C0037052 (UMLS CUI [10,1])
    C0443343 (UMLS CUI [10,2])
    C0264906 (UMLS CUI [11,1])
    C0443343 (UMLS CUI [11,2])
    C0151517 (UMLS CUI [12,1])
    C0443343 (UMLS CUI [12,2])
    Hypertensive Encephalopathy | Hypertensive Retinopathy Grade
    Item
    subject with history of hypertensive encephalopathy, grade 3 or 4 hypertensive retinopathy within 3 months before entering this trial
    boolean
    C0151620 (UMLS CUI [1])
    C0152132 (UMLS CUI [2,1])
    C0441800 (UMLS CUI [2,2])
    Cerebrovascular accident
    Item
    subjects with a cerebrovascular accident within 6 months before entering this trial
    boolean
    C0038454 (UMLS CUI [1])
    Autoimmune Disease
    Item
    subject with auto-immune disease
    boolean
    C0004364 (UMLS CUI [1])
    Endocrine System Diseases Uncontrolled | Hyperthyroidism | Hypothyroidism | Adrenal Gland Hyperfunction | Adrenal gland hypofunction
    Item
    subject with uncontrolled endocrine diseases, such as hyperthyroidism, hypothyroidism, hypercorticism and hypocorticism
    boolean
    C0014130 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0020550 (UMLS CUI [2])
    C0020676 (UMLS CUI [3])
    C0001622 (UMLS CUI [4])
    C0001623 (UMLS CUI [5])
    Renal Insufficiency | Serum creatinine raised
    Item
    subject with confirmed evidence of renal impairment (creatinine > 1.5 x upper limit of normal)
    boolean
    C1565489 (UMLS CUI [1])
    C0700225 (UMLS CUI [2])
    Hyperkalemia | Serum potassium measurement
    Item
    subject with hyperkalemia with serum potassium > 5.5 meq/l
    boolean
    C0020461 (UMLS CUI [1])
    C0302353 (UMLS CUI [2])
    Malignant disease End-stage
    Item
    subject with terminal stage of malignant disease
    boolean
    C0442867 (UMLS CUI [1,1])
    C0205088 (UMLS CUI [1,2])
    Substance Use Disorders
    Item
    subject with substance abuse history
    boolean
    C0038586 (UMLS CUI [1])
    Gastrointestinal Disease Interferes with Absorption Oral medication
    Item
    subject with gastrointestinal disease which can interfere the absorption of the oral medications
    boolean
    C0017178 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0237442 (UMLS CUI [1,3])
    C0175795 (UMLS CUI [1,4])
    Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers
    Item
    subject with any contraindication to the use of angiotensin ii receptor blocker or calcium channel blocker
    boolean
    C1301624 (UMLS CUI [1,1])
    C0521942 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [2,1])
    C0006684 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding
    Item
    subject is pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Premenopausal state Contraceptive methods Absent
    Item
    premenopausal subjects not taking reliable methods for contraceptives
    boolean
    C0232969 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    Disease Serious | Study Subject Participation Status Excluded
    Item
    subject with any other serious disease considered by the investigator not in the condition to enter the trial
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    Protocol Compliance Unable
    Item
    subject is not able to comply to the protocol requirements
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Study Subject Participation Status | Investigational New Drugs
    Item
    subject participated investigational drug trial within 3 months before entering this study
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
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