ID

39962

Descrição

Telmisartan 80mg Non-responder Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01222520

Link

https://clinicaltrials.gov/show/NCT01222520

Palavras-chave

Versões (1)
  1. 06/03/2020 06/03/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de março de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT01222520

Inglês

Eligibility Hypertension NCT01222520

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
essential hypertensive patients
Descrição

Essential Hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085580
if already taking antihypertensive drugs, mean seated diastolic blood pressure (dbp) must be >=90 and >=114 mmhg
Descrição

Antihypertensive Agents | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
if not taking any antihypertensive drugs, mean seated dbp must be >=95 and >=114 mmhg
Descrição

Antihypertensive Agents Absent | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
Descrição

Ability Discontinue Antihypertensive Agents | Risk Absent Patient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0003364
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0030705
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients taking 3 or more antihypertensive drugs at signing the informed consent form
Descrição

Antihypertensive Agents Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
patients with known or suspected secondary hypertension
Descrição

Secondary hypertension | Secondary hypertension Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
patients with clinically relevant cardiac arrhythmia
Descrição

Cardiac Arrhythmia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003811
congestive heart failure with new york heart association (nyha) functional class iii-iv
Descrição

Congestive heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
patients with recent cardiovascular events
Descrição

Cardiovascular event Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0332185
patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
Descrição

Cerebrovascular accident | Transient Ischemic Attack

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
patients with a history of sudden deterioration of renal function with angiotensin ii receptor blockers (arbs) or angiotensin converting enzyme (ace) inhibitors; or patients with post-renal transplant or post-nephrectomy
Descrição

Deterioration Sudden Renal function | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Status post Kidney Transplantation | Status post Nephrectomy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0868945
UMLS CUI [1,2]
C1276802
UMLS CUI [1,3]
C0232804
UMLS CUI [2]
C0521942
UMLS CUI [3]
C0003015
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0022671
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0027695
patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with arbs or ace inhibitors
Descrição

Symptoms Angioedema | Facial swelling with Dyspnea | Tongue swelling with Dyspnea | Pharyngeal swelling with Dyspnea | Laryngeal Edema with Dyspnea

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0002994
UMLS CUI [2,1]
C0151602
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0013404
UMLS CUI [3,1]
C0236068
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0013404
UMLS CUI [4,1]
C1704205
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C0013404
UMLS CUI [5,1]
C0023052
UMLS CUI [5,2]
C0332287
UMLS CUI [5,3]
C0013404
patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
Descrição

Hypersensitivity Investigational New Drug Component | Hypersensitivity Dihydropyridine derivatives

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3653438
patients with hepatic and/or renal dysfunction
Descrição

Liver Dysfunction | Renal dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
pre-menopausal women who are nursing or pregnant
Descrição

Premenopausal state | Breast Feeding | Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032961
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Similar models

Eligibility Hypertension NCT01222520

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
essential hypertensive patients
boolean
C0085580 (UMLS CUI [1])
Antihypertensive Agents | Sitting diastolic blood pressure mean
Item
if already taking antihypertensive drugs, mean seated diastolic blood pressure (dbp) must be >=90 and >=114 mmhg
boolean
C0003364 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Antihypertensive Agents Absent | Sitting diastolic blood pressure mean
Item
if not taking any antihypertensive drugs, mean seated dbp must be >=95 and >=114 mmhg
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Ability Discontinue Antihypertensive Agents | Risk Absent Patient
Item
able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
boolean
C0085732 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity
Item
patients taking 3 or more antihypertensive drugs at signing the informed consent form
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Secondary hypertension | Secondary hypertension Suspected
Item
patients with known or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Cardiac Arrhythmia
Item
patients with clinically relevant cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure with new york heart association (nyha) functional class iii-iv
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiovascular event Recent
Item
patients with recent cardiovascular events
boolean
C1320716 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Deterioration Sudden Renal function | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Status post Kidney Transplantation | Status post Nephrectomy
Item
patients with a history of sudden deterioration of renal function with angiotensin ii receptor blockers (arbs) or angiotensin converting enzyme (ace) inhibitors; or patients with post-renal transplant or post-nephrectomy
boolean
C0868945 (UMLS CUI [1,1])
C1276802 (UMLS CUI [1,2])
C0232804 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0022671 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0027695 (UMLS CUI [5,2])
Symptoms Angioedema | Facial swelling with Dyspnea | Tongue swelling with Dyspnea | Pharyngeal swelling with Dyspnea | Laryngeal Edema with Dyspnea
Item
patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with arbs or ace inhibitors
boolean
C1457887 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0151602 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0013404 (UMLS CUI [2,3])
C0236068 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0013404 (UMLS CUI [3,3])
C1704205 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0013404 (UMLS CUI [4,3])
C0023052 (UMLS CUI [5,1])
C0332287 (UMLS CUI [5,2])
C0013404 (UMLS CUI [5,3])
Hypersensitivity Investigational New Drug Component | Hypersensitivity Dihydropyridine derivatives
Item
patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C3653438 (UMLS CUI [2,2])
Liver Dysfunction | Renal dysfunction
Item
patients with hepatic and/or renal dysfunction
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Premenopausal state | Breast Feeding | Pregnancy
Item
pre-menopausal women who are nursing or pregnant
boolean
C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
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