Informações:
Falhas:
ID
12008
Descrição
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
Palavras-chave
Versões (1)
- 01/09/2015 01/09/2015 -
Titular dos direitos
ODM derived from: https://clinicaltrials.gov/show/NCT02047019
Transferido a
1 de setembro de 2015
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Hypertension NCT02047019
Eligibility Hypertension NCT02047019
- StudyEvent: Eligibility
Similar models
Eligibility Hypertension NCT02047019
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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])
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])
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])
C0011860 (UMLS CUI [2])