ID

29882

Descrição

Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00413413

Link

https://clinicaltrials.gov/show/NCT00413413

Palavras-chave

Versões (1)
  1. 25/04/2018 25/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de abril de 2018

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.

Voltar para os comentários do modelo
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 NCT00413413

Inglês

Eligibility Hypertension NCT00413413

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients >= 18 years and < 86 years
Descrição

Outpatients | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with essential diastolic hypertension
Descrição

Essential diastolic hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3694763
at visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmhg and < 10 mmhg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmhg
Descrição

Visit Number | Sitting diastolic blood pressure mean | Antihypertensive Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1549755
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3]
C0003364
at visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmhg and < 100 mmhg
Descrição

Visit Number | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1549755
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
at visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmhg and < 110 mmhg
Descrição

Visit Number | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1549755
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension >= 180/110 mmhg
Descrição

Hypertension, severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4013784
known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
Descrição

Medical contraindication Valsartan | Medical contraindication Suspected Valsartan | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypersensitivity Valsartan | Amlodipine allergy | Hypersensitivity Pharmaceutical Preparations Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0216784
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0216784
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0051696
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0051696
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0216784
UMLS CUI [6]
C0570921
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C2348205
inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to visit 2
Descrição

Antihypertensive Agents Unable to discontinue

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1548265
history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
Descrição

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0581603
malignant hypertension
Descrição

Malignant Hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020540
all patients with type i diabetes and those patients with type 2 diabetes who are not well controlled based on the investigator's clinical judgment
Descrição

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
pregnant or nursing women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of heart failure
Descrição

Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018801
angina pectoris
Descrição

Angina Pectoris

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002962
second or third degree heart block
Descrição

Second degree atrioventricular block | Complete atrioventricular block

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
life threatening or symptomatic arrhythmias
Descrição

Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0741212
clinically significant valvular heart disease
Descrição

Heart valve disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
evidence of a secondary form of hypertension
Descrição

Secondary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
known or moderate malignant retinopathy
Descrição

Retinal Disease Malignant | Retinal Disease Malignant Moderate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205282
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C0205081
evidence of hepatic disease
Descrição

Liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
evidence of renal impairment
Descrição

Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
other protocol-defined exclusion criteria may apply.
Descrição

Exclusion Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
Voltar ao início da página

Similar models

Eligibility Hypertension NCT00413413

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male or female outpatients >= 18 years and < 86 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential diastolic hypertension
Item
patients with essential diastolic hypertension
boolean
C3694763 (UMLS CUI [1])
Visit Number | Sitting diastolic blood pressure mean | Antihypertensive Agents
Item
at visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmhg and < 10 mmhg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3])
Visit Number | Sitting diastolic blood pressure mean
Item
at visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmhg and < 100 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Visit Number | Sitting diastolic blood pressure mean
Item
at visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmhg and < 110 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
severe hypertension >= 180/110 mmhg
boolean
C4013784 (UMLS CUI [1])
Medical contraindication Valsartan | Medical contraindication Suspected Valsartan | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypersensitivity Valsartan | Amlodipine allergy | Hypersensitivity Pharmaceutical Preparations Similar
Item
known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
boolean
C1301624 (UMLS CUI [1,1])
C0216784 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0216784 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0051696 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0051696 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0216784 (UMLS CUI [5,2])
C0570921 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C2348205 (UMLS CUI [7,3])
Antihypertensive Agents Unable to discontinue
Item
inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to visit 2
boolean
C0003364 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization
Item
history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
all patients with type i diabetes and those patients with type 2 diabetes who are not well controlled based on the investigator's clinical judgment
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart failure
Item
history of heart failure
boolean
C0018801 (UMLS CUI [1])
Angina Pectoris
Item
angina pectoris
boolean
C0002962 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block
Item
second or third degree heart block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC
Item
life threatening or symptomatic arrhythmias
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
Heart valve disease
Item
clinically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1])
Secondary hypertension
Item
evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Retinal Disease Malignant | Retinal Disease Malignant Moderate
Item
known or moderate malignant retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
Liver disease
Item
evidence of hepatic disease
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency
Item
evidence of renal impairment
boolean
C1565489 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial