ID

13218

Beschrijving

Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02177331

Link

https://clinicaltrials.gov/show/NCT02177331

Trefwoorden

  1. 24-01-16 24-01-16 -
Geüploaded op

24 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hypertension NCT02177331

Eligibility Hypertension NCT02177331

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
fulfillment of entry criteria for the preceding yearly study
Beschrijving

ID.1

Datatype

boolean

male or female patients aged between 20 and 85 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
known history of mild to moderate essential hypertension requiring drug treatment, who grade i to ii
Beschrijving

essential hypertension. who grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0013216
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0013216
controlled blood pressure (rr diastolic ≤ 90 mm hg or 91 - 95 mm hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
Beschrijving

blood pressure, lacidipine

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C0064568
final visit of the previous yearly study (visit 4) completed as scheduled
Beschrijving

ID.5

Datatype

boolean

informed consent to participate in the follow-up study
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
violation of entry/exclusion criteria on enrolment in the preceding yearly study
Beschrijving

ID.7

Datatype

boolean

occurrence of the following exclusion criteria in the intervening period:
Beschrijving

ID.8

Datatype

boolean

pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
Beschrijving

pregnancy, lactation, possibility of conception

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
secondary form of hypertension
Beschrijving

secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
consumptive illness
Beschrijving

consumptive illness

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (nyha class iii or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
Beschrijving

cardiovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
Beschrijving

myocardial infarction, cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
hypersensitivity to dihydropyridines
Beschrijving

hypersensitivity to dihydropyridines

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012315
concomitant long-term treatment (> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
Beschrijving

antihypertensive agents, sedatives, tricyclic antidepressants

Datatype

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0036557
UMLS CUI [3]
C0003290
suspected alcohol, narcotic or drug abuse
Beschrijving

suspected alcohol, narcotic or drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0038586

Similar models

Eligibility Hypertension NCT02177331

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
fulfillment of entry criteria for the preceding yearly study
boolean
Age
Item
male or female patients aged between 20 and 85 years
boolean
C0001779 (UMLS CUI [1])
essential hypertension. who grade
Item
known history of mild to moderate essential hypertension requiring drug treatment, who grade i to ii
boolean
C0085580 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
blood pressure, lacidipine
Item
controlled blood pressure (rr diastolic ≤ 90 mm hg or 91 - 95 mm hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
boolean
C0005823 (UMLS CUI [1])
C0064568 (UMLS CUI [2])
ID.5
Item
final visit of the previous yearly study (visit 4) completed as scheduled
boolean
informed consent
Item
informed consent to participate in the follow-up study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
violation of entry/exclusion criteria on enrolment in the preceding yearly study
boolean
ID.8
Item
occurrence of the following exclusion criteria in the intervening period:
boolean
pregnancy, lactation, possibility of conception
Item
pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
secondary hypertension
Item
secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
consumptive illness
Item
consumptive illness
boolean
C0009488 (UMLS CUI [1])
cardiovascular disease
Item
clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (nyha class iii or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
boolean
C0007222 (UMLS CUI [1])
myocardial infarction, cerebrovascular accident
Item
myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
hypersensitivity to dihydropyridines
Item
hypersensitivity to dihydropyridines
boolean
C0020517 (UMLS CUI [1,1])
C0012315 (UMLS CUI [1,2])
antihypertensive agents, sedatives, tricyclic antidepressants
Item
concomitant long-term treatment (> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
boolean
C0003364 (UMLS CUI [1])
C0036557 (UMLS CUI [2])
C0003290 (UMLS CUI [3])
suspected alcohol, narcotic or drug abuse
Item
suspected alcohol, narcotic or drug abuse
boolean
C0038586 (UMLS CUI [1])

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