ID

39242

Descrição

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01615198

Link

https://clinicaltrials.gov/show/NCT01615198

Palavras-chave

Versões (1)
  1. 11/12/2019 11/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01615198

Inglês

Eligibility Essential Hypertension NCT01615198

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must give written informed consent before any assessment is performed
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmhg and < 180 mmhg
Descrição

Essential Hypertension | Patients untreated | Antihypertensive therapy | Sitting systolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0585941
UMLS CUI [4,1]
C1319893
UMLS CUI [4,2]
C0444504
patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
Descrição

Able to communicate | Protocol Compliance | Compliance Pharmaceutical Preparations

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0013227
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with severe hypertension. patients with history of angioedema, drug-related or otherwise
Descrição

Hypertension, severe | Angioedema Drug-induced | Angioedema

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C0002994
UMLS CUI [2,2]
C0458082
UMLS CUI [3]
C0002994
patients with history or evidence of a secondary form of hypertension
Descrição

Secondary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke
Descrição

Transient Ischemic Attack | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
history of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1.
Descrição

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
Descrição

Angina Pectoris Requirement Pharmaceutical Preparations | Exception Nitrates Oral | Exception Nitrates Topical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028125
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028125
UMLS CUI [3,3]
C1522168
patients with type 1 or type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
Descrição

Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Absence Antidiabetics Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0935929
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
patients with previous or current diagnosis of heart failure (nyha class ii-iv).
Descrição

Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
patients with a clinically significant valvular heart disease at the time of screening
Descrição

Heart valve disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
women of child-bearing potential, who do not use adequate birth control methods other protocol-defined inclusion/exclusion criteria may apply
Descrição

Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C2348563
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Similar models

Eligibility Essential Hypertension NCT01615198

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients must give written informed consent before any assessment is performed
boolean
C0021430 (UMLS CUI [1])
Essential Hypertension | Patients untreated | Antihypertensive therapy | Sitting systolic blood pressure mean
Item
patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmhg and < 180 mmhg
boolean
C0085580 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0585941 (UMLS CUI [3])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
Able to communicate | Protocol Compliance | Compliance Pharmaceutical Preparations
Item
patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
boolean
C2364293 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Angioedema Drug-induced | Angioedema
Item
patients with severe hypertension. patients with history of angioedema, drug-related or otherwise
boolean
C4013784 (UMLS CUI [1])
C0002994 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C0002994 (UMLS CUI [3])
Secondary hypertension
Item
patients with history or evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Transient Ischemic Attack | Cerebrovascular accident
Item
transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Angina Pectoris Requirement Pharmaceutical Preparations | Exception Nitrates Oral | Exception Nitrates Topical
Item
current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
boolean
C0002962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0028125 (UMLS CUI [3,2])
C1522168 (UMLS CUI [3,3])
Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Absence Antidiabetics Dose Stable
Item
patients with type 1 or type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
boolean
C0011854 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0935929 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Heart failure New York Heart Association Classification
Item
patients with previous or current diagnosis of heart failure (nyha class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Heart valve disease
Item
patients with a clinically significant valvular heart disease at the time of screening
boolean
C0018824 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol
Item
women of child-bearing potential, who do not use adequate birth control methods other protocol-defined inclusion/exclusion criteria may apply
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
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