ID

40129

Description

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

Keywords

Versions (1)
  1. 3/13/20 3/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 13, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01788358

English

Eligibility Hypertension NCT01788358

1 forms  
Inclusion Criteria
Description

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.
Description

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

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

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

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

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
Description

Sitting diastolic blood pressure mean

Data type

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
Description

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

Data type

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
Description

Hypertensive emergency

Data type

boolean

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

Secondary hypertension | Aortic coarctation | Pheochromocytoma | Hyperaldosteronism

Data type

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
Description

Ischemic stroke | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

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

Cerebral Hemorrhage | Subarachnoid Hemorrhage

Data type

boolean

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

Hypertensive Retinopathy Grade

Data type

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
Description

Heart failure New York Heart Association Classification

Data type

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
Description

Coronary heart disease Severe | Myocardial Infarction | Angina, Unstable

Data type

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.
Description

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

Data type

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
Description

Hyperkalemia | Serum potassium increased

Data type

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0553704
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Similar models

Eligibility Hypertension NCT01788358

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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