ID

29993

Descrição

Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00940667

Link

https://clinicaltrials.gov/show/NCT00940667

Palavras-chave

Versões (1)
  1. 03/05/2018 03/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de maio de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT00940667

Inglês

Eligibility Hypertension NCT00940667

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
essential hypertensive patients whose blood pressure is not controlled before the study (sit dbp ≥ 90 mmhg for drug-treated patient, sit dbp ≥ 95 mmhg for drug-naïve patient)
Descrição

Essential Hypertension | Blood Pressure Uncontrolled Before Clinical Trial | Sitting diastolic blood pressure Pharmacotherapy | Sitting diastolic blood pressure Pharmacotherapy naive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0013216
UMLS CUI [4,1]
C1319894
UMLS CUI [4,2]
C0013216
UMLS CUI [4,3]
C0919936
non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit dbp ≥ 90mmhg)
Descrição

Amlodipine Unresponsive to Treatment | Sitting diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0051696
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1319894
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
mean sit sbp ≥ 200 mmhg or mean sit dbp ≥ 120 mmhg at screening
Descrição

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
mean sit sbp ≥ 180 mmhg or mean sit dbp ≥ 120 mmhg after 4 weeks of amlodipine 5 mg treatment
Descrição

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Amlodipine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3]
C0051696
has a history of hypersensitivity to dihydropyridines or angiotensin ii receptor blockers
Descrição

Hypersensitivity Dihydropyridines | Allergy to angiotensin II receptor antagonist

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012315
UMLS CUI [2]
C2585204
secondary hypertensive patient or suspected to be
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
uncontrolled diabetes mellitus patients
Descrição

Diabetic - poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
severe heart disease or severe neurovascular disease
Descrição

Heart Disease Severe | Neurovascular Disorder Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3898144
UMLS CUI [2,2]
C0205082
known as severe or malignant retinopathy
Descrição

Retinal Disease Severe | Retinal Disease Malignant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205282
patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (alt or ast)
Descrição

Hematological Disease | Kidney Disease | Creatinine measurement, serum | Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
history of malignancy tumor
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
history of autoimmune disease
Descrição

Autoimmune Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
history of alcohol or drug abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
positive to pregnancy test, nursing mother, has an intention on pregnancy
Descrição

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
considered by investigator as not appropriate to participate in the clinical study with othe reason
Descrição

Other Reason Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Hypertension NCT00940667

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension | Blood Pressure Uncontrolled Before Clinical Trial | Sitting diastolic blood pressure Pharmacotherapy | Sitting diastolic blood pressure Pharmacotherapy naive
Item
essential hypertensive patients whose blood pressure is not controlled before the study (sit dbp ≥ 90 mmhg for drug-treated patient, sit dbp ≥ 95 mmhg for drug-naïve patient)
boolean
C0085580 (UMLS CUI [1])
C0005823 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C1319894 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C1319894 (UMLS CUI [4,1])
C0013216 (UMLS CUI [4,2])
C0919936 (UMLS CUI [4,3])
Amlodipine Unresponsive to Treatment | Sitting diastolic blood pressure
Item
non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit dbp ≥ 90mmhg)
boolean
C0051696 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mean sit sbp ≥ 200 mmhg or mean sit dbp ≥ 120 mmhg at screening
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Amlodipine
Item
mean sit sbp ≥ 180 mmhg or mean sit dbp ≥ 120 mmhg after 4 weeks of amlodipine 5 mg treatment
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0051696 (UMLS CUI [3])
Hypersensitivity Dihydropyridines | Allergy to angiotensin II receptor antagonist
Item
has a history of hypersensitivity to dihydropyridines or angiotensin ii receptor blockers
boolean
C0020517 (UMLS CUI [1,1])
C0012315 (UMLS CUI [1,2])
C2585204 (UMLS CUI [2])
Secondary hypertension | Secondary hypertension Suspected
Item
secondary hypertensive patient or suspected to be
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Diabetic - poor control
Item
uncontrolled diabetes mellitus patients
boolean
C0421258 (UMLS CUI [1])
Heart Disease Severe | Neurovascular Disorder Severe
Item
severe heart disease or severe neurovascular disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3898144 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Retinal Disease Severe | Retinal Disease Malignant
Item
known as severe or malignant retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
Hematological Disease | Kidney Disease | Creatinine measurement, serum | Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (alt or ast)
boolean
C0018939 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Malignant Neoplasms
Item
history of malignancy tumor
boolean
C0006826 (UMLS CUI [1])
Autoimmune Disease
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Substance Use Disorders
Item
history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
positive to pregnancy test, nursing mother, has an intention on pregnancy
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Other Reason Study Subject Participation Status Inappropriate
Item
considered by investigator as not appropriate to participate in the clinical study with othe reason
boolean
C3840932 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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