ID

30815

Beskrivning

Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00710372

Länk

https://clinicaltrials.gov/show/NCT00710372

Nyckelord

Versioner (1)
  1. 2018-06-22 2018-06-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mild Essential Hypertension NCT00710372

Engelsk

Eligibility Mild Essential Hypertension NCT00710372

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with mild to moderate essential hypertension (grade i and grade ii) with mean sitting office sbp =140-179 mmhg and/or mean sitting office dbp = 90 -109 mmhg on 2 consecutive visits (screening and v1).
Beskrivning

Essential Hypertension Mild Grade | Essential Hypertension Moderate Grade | Sitting systolic blood pressure mean Patient Visit Quantity | Sitting diastolic blood pressure mean Patient Visit Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0441800
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
UMLS CUI [3,3]
C1512346
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C1319894
UMLS CUI [4,2]
C0444504
UMLS CUI [4,3]
C1512346
UMLS CUI [4,4]
C1265611
daytime blood pressure above threshold for definition of hypertension in the baseline abpm measurement (sbp >135 mmhg).
Beskrivning

Blood pressure determination Daytime | Blood Pressure Monitoring, Ambulatory | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0332169
UMLS CUI [2]
C0242876
UMLS CUI [3]
C0871470
stable baseline blood pressure confirmed on 2 consecutive visits (screening and v1). (changes <20mmhg for sitting office sbp and <10mmhg for mean sitting office dpb).
Beskrivning

Stable blood pressure Patient Visit Quantity | Change Amount Sitting systolic blood pressure | Change Amount Sitting diastolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428896
UMLS CUI [1,2]
C1512346
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1319893
UMLS CUI [3,1]
C0392747
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1319894
UMLS CUI [3,4]
C0444504
patients without current antihypertensive therapy. patients on previous mono-antihypertensive therapy, who can safely stop their medication
Beskrivning

Antihypertensive therapy Absent | Antihypertensive therapy Previous | Stop medication Possible

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0850893
UMLS CUI [3,2]
C0332149
patient is willing and able to comply with all trial requirements and procedures.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with "very high added risk" according to 2007 guidelines for the management of arterial hypertension (journal of hypertension, 2007, 25:1105- 1187), i.e. those with:grade iii hypertension (mean sitting office sbp
Beskrivning

Hypertensive disease Grade | Sitting systolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
180mmhg and/or meansitting dbp ≥110mmhg/history or presence of established cardiovascular or renal disease (ischemic stroke, cerebral hemorrhage, transient ischemic attack)/ myocardial infarction, angina pectoris, coronary re-vascularization/ clinically relevant heart failure (nyha class ii-iv)/
Beskrivning

Sitting diastolic blood pressure mean | Cardiovascular Disease Established | Kidney Disease Established | Ischemic stroke | Cerebral Hemorrhage | Transient Ischemic Attack | Myocardial Infarction | Angina Pectoris | Coronary revascularisation | Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0443211
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0443211
UMLS CUI [4]
C0948008
UMLS CUI [5]
C2937358
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0027051
UMLS CUI [8]
C0002962
UMLS CUI [9]
C0877341
UMLS CUI [10,1]
C0018801
UMLS CUI [10,2]
C1275491
peripheral artery disease/ diabetic nephropathy
Beskrivning

Peripheral Arterial Diseases | Diabetic Nephropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C1704436
UMLS CUI [2]
C0011881
electrocardiographic confirmed left ventricular hypertrophy
Beskrivning

Left Ventricular Hypertrophy Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149721
UMLS CUI [1,2]
C1623258
increased plasma creatinine
Beskrivning

Plasma creatinine increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0858118
diabetes mellitus type i, history, presence or new diagnosis of diabetes mellitus type ii.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus New diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C2585997
postural hypotension at screening
Beskrivning

Hypotension, Orthostatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0020651
arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.
Beskrivning

Cardiac Arrhythmia Interferes with Oscillometry Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0029375
UMLS CUI [1,4]
C0005823
known autoimmune disease.
Beskrivning

Autoimmune Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
severe allergy.
Beskrivning

Severe allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C2945656
pregnancy or breastfeeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women in childbearing age that are not surgically sterilized.
Beskrivning

Childbearing Potential Female Sterilization Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0015787
UMLS CUI [1,3]
C0332197
patients with a history or current positive test for hiv infection, aids, or other immunosuppressive disorders; hepatitis b or c.
Beskrivning

HIV Seropositivity | Immunosuppression Positive | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0856706
UMLS CUI [4]
C1112419
current diagnosis or history of malignancy.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Mild Essential Hypertension NCT00710372

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Mild Grade | Essential Hypertension Moderate Grade | Sitting systolic blood pressure mean Patient Visit Quantity | Sitting diastolic blood pressure mean Patient Visit Quantity
Item
patients with mild to moderate essential hypertension (grade i and grade ii) with mean sitting office sbp =140-179 mmhg and/or mean sitting office dbp = 90 -109 mmhg on 2 consecutive visits (screening and v1).
boolean
C0085580 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0085580 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1512346 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C1319894 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
C1512346 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Blood pressure determination Daytime | Blood Pressure Monitoring, Ambulatory | Systolic Pressure
Item
daytime blood pressure above threshold for definition of hypertension in the baseline abpm measurement (sbp >135 mmhg).
boolean
C0005824 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0242876 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Stable blood pressure Patient Visit Quantity | Change Amount Sitting systolic blood pressure | Change Amount Sitting diastolic blood pressure mean
Item
stable baseline blood pressure confirmed on 2 consecutive visits (screening and v1). (changes <20mmhg for sitting office sbp and <10mmhg for mean sitting office dpb).
boolean
C0428896 (UMLS CUI [1,1])
C1512346 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0392747 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1319893 (UMLS CUI [2,3])
C0392747 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1319894 (UMLS CUI [3,3])
C0444504 (UMLS CUI [3,4])
Antihypertensive therapy Absent | Antihypertensive therapy Previous | Stop medication Possible
Item
patients without current antihypertensive therapy. patients on previous mono-antihypertensive therapy, who can safely stop their medication
boolean
C0585941 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0850893 (UMLS CUI [3,1])
C0332149 (UMLS CUI [3,2])
Protocol Compliance
Item
patient is willing and able to comply with all trial requirements and procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypertensive disease Grade | Sitting systolic blood pressure mean
Item
patients with "very high added risk" according to 2007 guidelines for the management of arterial hypertension (journal of hypertension, 2007, 25:1105- 1187), i.e. those with:grade iii hypertension (mean sitting office sbp
boolean
C0020538 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Sitting diastolic blood pressure mean | Cardiovascular Disease Established | Kidney Disease Established | Ischemic stroke | Cerebral Hemorrhage | Transient Ischemic Attack | Myocardial Infarction | Angina Pectoris | Coronary revascularisation | Heart failure New York Heart Association Classification
Item
180mmhg and/or meansitting dbp ≥110mmhg/history or presence of established cardiovascular or renal disease (ischemic stroke, cerebral hemorrhage, transient ischemic attack)/ myocardial infarction, angina pectoris, coronary re-vascularization/ clinically relevant heart failure (nyha class ii-iv)/
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0443211 (UMLS CUI [3,2])
C0948008 (UMLS CUI [4])
C2937358 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C0002962 (UMLS CUI [8])
C0877341 (UMLS CUI [9])
C0018801 (UMLS CUI [10,1])
C1275491 (UMLS CUI [10,2])
Peripheral Arterial Diseases | Diabetic Nephropathy
Item
peripheral artery disease/ diabetic nephropathy
boolean
C1704436 (UMLS CUI [1])
C0011881 (UMLS CUI [2])
Left Ventricular Hypertrophy Electrocardiography
Item
electrocardiographic confirmed left ventricular hypertrophy
boolean
C0149721 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Plasma creatinine increased
Item
increased plasma creatinine
boolean
C0858118 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus New diagnosis
Item
diabetes mellitus type i, history, presence or new diagnosis of diabetes mellitus type ii.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0011860 (UMLS CUI [3,1])
C2585997 (UMLS CUI [3,2])
Hypotension, Orthostatic
Item
postural hypotension at screening
boolean
C0020651 (UMLS CUI [1])
Cardiac Arrhythmia Interferes with Oscillometry Blood Pressure
Item
arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.
boolean
C0003811 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0029375 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
Autoimmune Diseases
Item
known autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Severe allergy
Item
severe allergy.
boolean
C2945656 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Female Sterilization Absent
Item
women in childbearing age that are not surgically sterilized.
boolean
C3831118 (UMLS CUI [1,1])
C0015787 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
HIV Seropositivity | Immunosuppression Positive | Hepatitis B positive | Hepatitis C positive
Item
patients with a history or current positive test for hiv infection, aids, or other immunosuppressive disorders; hepatitis b or c.
boolean
C0019699 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0856706 (UMLS CUI [3])
C1112419 (UMLS CUI [4])
Malignant Neoplasms
Item
current diagnosis or history of malignancy.
boolean
C0006826 (UMLS CUI [1])
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