ID

40129

Beschrijving

Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01788358

Link

https://clinicaltrials.gov/show/NCT01788358

Trefwoorden

Versies (1)
  1. 13-03-20 13-03-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 maart 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hypertension NCT01788358

Engels

Eligibility Hypertension NCT01788358

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have moderate to severe essential hypertension (grade 2 or grade 3, who classifications). at visit 1, subjects not treated with antihypertensive medications are to have mssbp of >/= 160 mmhg and < 200 mmhg, as measured by a calibrated electronic bp measuring device. for other subjects who are treated with antihypertensive medication before, they should have mssbp >/= 160 mmhg and <200 mmhg after wash out.
Beschrijving

Essential Hypertension Moderate Grade WHO classification | Essential Hypertension Severe Grade WHO classification | Antihypertensive Agents Absent | Sitting systolic blood pressure mean | Antihypertensive Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C4267671
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0441800
UMLS CUI [2,4]
C4267671
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1319893
UMLS CUI [4,2]
C0444504
UMLS CUI [5]
C0003364
women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active
Beschrijving

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Exception Hormonal Oral Contraceptives

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009907
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mean seated systolic blood pressure >/= 200 mmhg and/or mean seated diastolic blood pressure >/= 120 mm/hg
Beschrijving

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
mean seated diastolic blood pressure < 60 mm/hg
Beschrijving

Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
differences greater than 20 mmhg for systolic blood pressure and 10 mmhg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
Beschrijving

Difference | Systolic Pressure | Diastolic blood pressure | Blood pressure determination Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C1705242
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0005824
UMLS CUI [4,2]
C1265611
any history of hypertensive emergency
Beschrijving

Hypertensive emergency

Datatype

boolean

Alias
UMLS CUI [1]
C0745136
evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
Beschrijving

Secondary hypertension | Aortic coarctation | Pheochromocytoma | Hyperaldosteronism

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0003492
UMLS CUI [3]
C0031511
UMLS CUI [4]
C0020428
cerebrovascular ischemic event (stroke, transient ischemic attack [tia])within the previous 12 months
Beschrijving

Ischemic stroke | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
history of intracerebral hemorrhage or subarachnoid hemorrhage
Beschrijving

Cerebral Hemorrhage | Subarachnoid Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C2937358
UMLS CUI [2]
C0038525
history of hypertensive retinopathy - known keith-wagener grade iii or iv
Beschrijving

Hypertensive Retinopathy Grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
any history of heart failure, new york heart association (nyha) classification iii or iv
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
Beschrijving

Coronary heart disease Severe | Myocardial Infarction | Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
type 1 diabetes mellitus (dm) or poorly controlled type 2 dm as evidenced by hba1c of greater than 9% on visit 0.
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0474680
hyperkalemia: potassium above the upper limit of normal in the laboratory range
Beschrijving

Hyperkalemia | Serum potassium increased

Datatype

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0553704
Terug naar het begin van de pagina

Similar models

Eligibility Hypertension NCT01788358

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Moderate Grade WHO classification | Essential Hypertension Severe Grade WHO classification | Antihypertensive Agents Absent | Sitting systolic blood pressure mean | Antihypertensive Agents
Item
subjects must have moderate to severe essential hypertension (grade 2 or grade 3, who classifications). at visit 1, subjects not treated with antihypertensive medications are to have mssbp of >/= 160 mmhg and < 200 mmhg, as measured by a calibrated electronic bp measuring device. for other subjects who are treated with antihypertensive medication before, they should have mssbp >/= 160 mmhg and <200 mmhg after wash out.
boolean
C0085580 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C4267671 (UMLS CUI [1,4])
C0085580 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
C4267671 (UMLS CUI [2,4])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
C0003364 (UMLS CUI [5])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Exception Hormonal Oral Contraceptives
Item
women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0009907 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mean seated systolic blood pressure >/= 200 mmhg and/or mean seated diastolic blood pressure >/= 120 mm/hg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Sitting diastolic blood pressure mean
Item
mean seated diastolic blood pressure < 60 mm/hg
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Difference | Systolic Pressure | Diastolic blood pressure | Blood pressure determination Quantity
Item
differences greater than 20 mmhg for systolic blood pressure and 10 mmhg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
boolean
C1705242 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0005824 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Hypertensive emergency
Item
any history of hypertensive emergency
boolean
C0745136 (UMLS CUI [1])
Secondary hypertension | Aortic coarctation | Pheochromocytoma | Hyperaldosteronism
Item
evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
boolean
C0155616 (UMLS CUI [1])
C0003492 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
C0020428 (UMLS CUI [4])
Ischemic stroke | Cerebrovascular accident | Transient Ischemic Attack
Item
cerebrovascular ischemic event (stroke, transient ischemic attack [tia])within the previous 12 months
boolean
C0948008 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Cerebral Hemorrhage | Subarachnoid Hemorrhage
Item
history of intracerebral hemorrhage or subarachnoid hemorrhage
boolean
C2937358 (UMLS CUI [1])
C0038525 (UMLS CUI [2])
Hypertensive Retinopathy Grade
Item
history of hypertensive retinopathy - known keith-wagener grade iii or iv
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Heart failure New York Heart Association Classification
Item
any history of heart failure, new york heart association (nyha) classification iii or iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Coronary heart disease Severe | Myocardial Infarction | Angina, Unstable
Item
severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
boolean
C0010068 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement
Item
type 1 diabetes mellitus (dm) or poorly controlled type 2 dm as evidenced by hba1c of greater than 9% on visit 0.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Hyperkalemia | Serum potassium increased
Item
hyperkalemia: potassium above the upper limit of normal in the laboratory range
boolean
C0020461 (UMLS CUI [1])
C0553704 (UMLS CUI [2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial