ID

40841

Beschrijving

Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399); ODM derived from: https://clinicaltrials.gov/show/NCT01277822

Link

https://clinicaltrials.gov/show/NCT01277822

Trefwoorden

Versies (1)
  1. 23-05-20 23-05-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 mei 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT01277822

Engels

Eligibility Hypertension NCT01277822

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with essential hypertension:
Beschrijving

Essential Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
who are on single drug therapy
Beschrijving

Pharmacotherapy Drug Single

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205171
who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
Beschrijving

Newly Diagnosed | Pharmacotherapy Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1518321
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
who have blood pressure readings of 90mmhg ≤ msdbp < 110mmhg and 140mmhg ≤ mssbp <180mmhg after 2 weeks wash-out for patients on single agent.
Beschrijving

Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean | Status post Washout Period

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1710661
randomization (visit 3)
Beschrijving

Randomization

Datatype

boolean

Alias
UMLS CUI [1]
C0034656
after dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:
Beschrijving

Status post Amlodipine Unit dose | Blood pressure determination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0051696
UMLS CUI [1,3]
C0869039
UMLS CUI [2]
C0005824
90mmhg ≤ msdbp < 110mmhg and 140mmhg ≤ mssbp < 180mmhg.
Beschrijving

Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant with msdbp ≥ 110mmhg or mssbp ≥ 180mmhg.
Beschrijving

Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
Beschrijving

Antihypertensive Agents Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
participant with known secondary hypertension of any etiology.
Beschrijving

Secondary hypertension | Etiology Any

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1552551
participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
Beschrijving

Malignant Hypertension | Malignant Hypertension Impending | Headache | Papilledema | Myocardial Ischemia | Pulmonary congestion Precipitated by Elevated blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0020540
UMLS CUI [2,1]
C0020540
UMLS CUI [2,2]
C0332190
UMLS CUI [3]
C0018681
UMLS CUI [4]
C0030353
UMLS CUI [5]
C0151744
UMLS CUI [6,1]
C0242073
UMLS CUI [6,2]
C1444748
UMLS CUI [6,3]
C0497247
participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin ii receptor blockers.
Beschrijving

Intolerance to Component Dihydropyridines | Medical contraindication Component Dihydropyridines | Hypersensitivity Component Dihydropyridines | Intolerance to Component Angiotensin II receptor antagonist | Medical contraindication Component Angiotensin II receptor antagonist | Hypersensitivity Component Angiotensin II receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0012315
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0012315
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1705248
UMLS CUI [3,3]
C0012315
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1705248
UMLS CUI [4,3]
C0521942
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C1705248
UMLS CUI [5,3]
C0521942
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C1705248
UMLS CUI [6,3]
C0521942
participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.
Beschrijving

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Hypertension NCT01277822

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
participants with essential hypertension:
boolean
C0085580 (UMLS CUI [1])
Pharmacotherapy Drug Single
Item
who are on single drug therapy
boolean
C0013216 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Newly Diagnosed | Pharmacotherapy Absent
Item
who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
boolean
C1518321 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean | Status post Washout Period
Item
who have blood pressure readings of 90mmhg ≤ msdbp < 110mmhg and 140mmhg ≤ mssbp <180mmhg after 2 weeks wash-out for patients on single agent.
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1710661 (UMLS CUI [3,2])
Randomization
Item
randomization (visit 3)
boolean
C0034656 (UMLS CUI [1])
Status post Amlodipine Unit dose | Blood pressure determination
Item
after dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:
boolean
C0231290 (UMLS CUI [1,1])
C0051696 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
C0005824 (UMLS CUI [2])
Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
90mmhg ≤ msdbp < 110mmhg and 140mmhg ≤ mssbp < 180mmhg.
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
participant with msdbp ≥ 110mmhg or mssbp ≥ 180mmhg.
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Antihypertensive Agents Quantity
Item
participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Secondary hypertension | Etiology Any
Item
participant with known secondary hypertension of any etiology.
boolean
C0155616 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Malignant Hypertension | Malignant Hypertension Impending | Headache | Papilledema | Myocardial Ischemia | Pulmonary congestion Precipitated by Elevated blood pressure
Item
participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
boolean
C0020540 (UMLS CUI [1])
C0020540 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0018681 (UMLS CUI [3])
C0030353 (UMLS CUI [4])
C0151744 (UMLS CUI [5])
C0242073 (UMLS CUI [6,1])
C1444748 (UMLS CUI [6,2])
C0497247 (UMLS CUI [6,3])
Intolerance to Component Dihydropyridines | Medical contraindication Component Dihydropyridines | Hypersensitivity Component Dihydropyridines | Intolerance to Component Angiotensin II receptor antagonist | Medical contraindication Component Angiotensin II receptor antagonist | Hypersensitivity Component Angiotensin II receptor antagonist
Item
participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin ii receptor blockers.
boolean
C1744706 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0012315 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0012315 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C0012315 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C1705248 (UMLS CUI [4,2])
C0521942 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C1705248 (UMLS CUI [5,2])
C0521942 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C1705248 (UMLS CUI [6,2])
C0521942 (UMLS CUI [6,3])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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