ID

12008

Description

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil; ODM derived from: https://clinicaltrials.gov/show/NCT02047019

Link

https://clinicaltrials.gov/show/NCT02047019

Keywords

Versions (1)
  1. 9/1/15 9/1/15 -
Copyright Holder

ODM derived from: https://clinicaltrials.gov/show/NCT02047019

Uploaded on

September 1, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT02047019

English

Eligibility Hypertension NCT02047019

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

male and female subjects 18 years or older are eligible.
Description

aged 18 years or older; female

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0682069
at visit 0, subjects not treated with antihypertensive medications are to have mssbp (mean seated systolic blood pressure) of >/= 160 mmhg and < 200 mmhg, and 24 hours masbp (mean ambulatory systolic blood pressure) >/= 130 mmhg; those subjects treated with antihypertensive medication are to have mssbp >/= 150 mmhg and < 200 mmhg as measured by a calibrated electronic bp measuring device
Description

blood pressure; medications; not treated; ambulatory; systolic; device; visit

Data type

boolean

Alias
UMLS CUI [1]
C0277883
at visit 3,subject must have mssbp >/= 140 mmhg before randomization
Description

randomization; visit

Data type

boolean

Alias
UMLS CUI [1]
C0277883
women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. this applies since signing of the ic (informed consent)form until the last study drug administration.
Description

adequate contraception; childbearing potential; informed consent; contraceptives; hormonal; other; active; agree; study; last; drug

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

mean seated systolic blood pressure (mssbp) >/= 200 mmhg and/or mean seated diastolic blood pressure (msdbp) >/= 120 mm/hg
Description

diastolic blood pressure; systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0871470
mean seated diastolic blood pressure (msdbp) < 60 mm/hg
Description

diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428883
differences greater than 20 mmhg for systolic blood pressure (sbp) and 10 mmhg for diastolic blood pressure (dbp) are present on 3 consecutive blood pressure readings at visit 0
Description

systolic blood pressure (sbp); diastolic blood pressure; present; visit; dbp

Data type

boolean

Alias
UMLS CUI [1]
C3160850
evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
Description

hypertension; evidence of; aorta

Data type

boolean

Alias
UMLS CUI [1]
C0155616
cerebrovascular ischemic event (stroke, transient ischemic attack [tia]) within the previous 12 months
Description

transient ischemic attack; stroke; event

Data type

boolean

Alias
UMLS CUI [1]
C1561291
history of hypertensive retinopathy - known keith-wagener grade iii or iv. any history of heart failure, new york heart association (nyha) classification iii or iv
Description

new york heart association classification; heart failure; retinopathy; grade; iii

Data type

boolean

Alias
UMLS CUI [1]
C0152132
UMLS CUI [2]
C0018802
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

past history of myocardial infarction; coronary heart disease; unstable angina; severe; visit; last

Data type

boolean

Alias
UMLS CUI [1]
C0010068
clinically significant cardiac valvular disease
Description

clinically significant; disease; cardiac

Data type

boolean

Alias
UMLS CUI [1]
C0018824
subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study.
Description

aortic aneurysm; investigator; study

Data type

boolean

Alias
UMLS CUI [1]
C0003486
type 1 diabetes mellitus (dm) or poorly controlled type 2 dm as evidenced by glycosylated hemoglobin hba1c of greater than 9% on visit 0
Description

type 1 diabetes mellitus; hemoglobin; controlled; visit; hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
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Similar models

Eligibility Hypertension NCT02047019

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
aged 18 years or older; female
Item
male and female subjects 18 years or older are eligible.
boolean
C0001779 (UMLS CUI [1])
C0682069 (UMLS CUI [2])
blood pressure; medications; not treated; ambulatory; systolic; device; visit
Item
at visit 0, subjects not treated with antihypertensive medications are to have mssbp (mean seated systolic blood pressure) of >/= 160 mmhg and < 200 mmhg, and 24 hours masbp (mean ambulatory systolic blood pressure) >/= 130 mmhg; those subjects treated with antihypertensive medication are to have mssbp >/= 150 mmhg and < 200 mmhg as measured by a calibrated electronic bp measuring device
boolean
C0277883 (UMLS CUI [1])
randomization; visit
Item
at visit 3,subject must have mssbp >/= 140 mmhg before randomization
boolean
C0277883 (UMLS CUI [1])
adequate contraception; childbearing potential; informed consent; contraceptives; hormonal; other; active; agree; study; last; drug
Item
women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. this applies since signing of the ic (informed consent)form until the last study drug administration.
boolean
C0700589 (UMLS CUI [1])
diastolic blood pressure; systolic blood pressure
Item
mean seated systolic blood pressure (mssbp) >/= 200 mmhg and/or mean seated diastolic blood pressure (msdbp) >/= 120 mm/hg
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
diastolic blood pressure
Item
mean seated diastolic blood pressure (msdbp) < 60 mm/hg
boolean
C0428883 (UMLS CUI [1])
systolic blood pressure (sbp); diastolic blood pressure; present; visit; dbp
Item
differences greater than 20 mmhg for systolic blood pressure (sbp) and 10 mmhg for diastolic blood pressure (dbp) are present on 3 consecutive blood pressure readings at visit 0
boolean
C3160850 (UMLS CUI [1])
hypertension; evidence of; aorta
Item
evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
boolean
C0155616 (UMLS CUI [1])
transient ischemic attack; stroke; event
Item
cerebrovascular ischemic event (stroke, transient ischemic attack [tia]) within the previous 12 months
boolean
C1561291 (UMLS CUI [1])
new york heart association classification; heart failure; retinopathy; grade; iii
Item
history of hypertensive retinopathy - known keith-wagener grade iii or iv. any history of heart failure, new york heart association (nyha) classification iii or iv
boolean
C0152132 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
past history of myocardial infarction; coronary heart disease; unstable angina; severe; visit; last
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])
clinically significant; disease; cardiac
Item
clinically significant cardiac valvular disease
boolean
C0018824 (UMLS CUI [1])
aortic aneurysm; investigator; study
Item
subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study.
boolean
C0003486 (UMLS CUI [1])
type 1 diabetes mellitus; hemoglobin; controlled; visit; hba1c
Item
type 1 diabetes mellitus (dm) or poorly controlled type 2 dm as evidenced by glycosylated hemoglobin hba1c of greater than 9% on visit 0
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
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