ID

39242

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-12-19 11-12-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 december 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01615198

Engels

Eligibility Essential Hypertension NCT01615198

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Informed Consent

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Able to communicate | Protocol Compliance | Compliance Pharmaceutical Preparations

Datatype

boolean

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

Exclusion Criteria

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

Hypertension, severe | Angioedema Drug-induced | Angioedema

Datatype

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
Beschrijving

Secondary hypertension

Datatype

boolean

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

Transient Ischemic Attack | Cerebrovascular accident

Datatype

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.
Beschrijving

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datatype

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).
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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).
Beschrijving

Heart failure New York Heart Association Classification

Datatype

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
Beschrijving

Heart valve disease

Datatype

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
Beschrijving

Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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