ID

36108

Descripción

Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01865188

Link

https://clinicaltrials.gov/show/NCT01865188

Palabras clave

Versiones (1)
  1. 15/4/19 15/4/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de abril de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT01865188

Inglés

Eligibility Hypertension NCT01865188

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female outpatients
Descripción

Outpatients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
2. patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy
Descripción

Mild hypertension Untreated | Moderate hypertensive disease Untreated | Antihypertensive therapy Mild hypertension | Antihypertensive therapy Hypertensive disease Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3276943
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C0585941
UMLS CUI [3,2]
C3276943
UMLS CUI [4,1]
C0585941
UMLS CUI [4,2]
C0020538
UMLS CUI [4,3]
C0205081
3. treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and <180 mmhg at the randomization visit and mssbp ≥140 mmhg <180 mmhg at the preceding visit.
Descripción

Antihypertensive therapy | Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0034656
UMLS CUI [3,2]
C0008952
UMLS CUI [4,1]
C0008952
UMLS CUI [4,2]
C0332152
4. untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and <180 mmhg at both the randomization visit and the preceding visit.
Descripción

Patients Untreated | Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0034656
UMLS CUI [3,2]
C0008952
UMLS CUI [4,1]
C0008952
UMLS CUI [4,2]
C0332152
5. patients must have an absolute difference of ≤15 mmhg in mssbp between the randomization visit and the preceding visit.
Descripción

Difference Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1705242
UMLS CUI [1,2]
C1319893
UMLS CUI [1,3]
C0444504
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0008952
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C0332152
6. ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period.
Descripción

Able to communicate | Protocol Compliance | Medication Compliance Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C3489773
UMLS CUI [3,2]
C0439165
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg)
Descripción

Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
2. history of angioedema, drug-related or otherwise
Descripción

Angioedema Drug-induced | Angioedema

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C0458082
UMLS CUI [2]
C0002994
3. history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension
Descripción

Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Aortic coarctation | Primary hyperaldosteronism | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases | Hypertensive disease Drug-induced

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0264649
UMLS CUI [3]
C0020545
UMLS CUI [4]
C0856759
UMLS CUI [5]
C0856760
UMLS CUI [6]
C0003492
UMLS CUI [7]
C1384514
UMLS CUI [8]
C0221406
UMLS CUI [9]
C0031511
UMLS CUI [10]
C0022680
UMLS CUI [11,1]
C0020538
UMLS CUI [11,2]
C0458082
4. transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke
Descripción

Transient Ischemic Attack

Tipo de datos

boolean

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

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
6. pregnant or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. women of child-bearing potential not using highly effective methods of contraception other protocol defined inclusion/exclusion criteria may apply
Descripción

Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol

Tipo de datos

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 Hypertension NCT01865188

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients
Item
1. male or female outpatients
boolean
C0029921 (UMLS CUI [1])
Mild hypertension Untreated | Moderate hypertensive disease Untreated | Antihypertensive therapy Mild hypertension | Antihypertensive therapy Hypertensive disease Moderate
Item
2. patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy
boolean
C3276943 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0585941 (UMLS CUI [3,1])
C3276943 (UMLS CUI [3,2])
C0585941 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
C0205081 (UMLS CUI [4,3])
Antihypertensive therapy | Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding
Item
3. treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and <180 mmhg at the randomization visit and mssbp ≥140 mmhg <180 mmhg at the preceding visit.
boolean
C0585941 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
C0008952 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
Patients Untreated | Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding
Item
4. untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and <180 mmhg at both the randomization visit and the preceding visit.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
C0008952 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
Difference Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding
Item
5. patients must have an absolute difference of ≤15 mmhg in mssbp between the randomization visit and the preceding visit.
boolean
C1705242 (UMLS CUI [1,1])
C1319893 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0034656 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Able to communicate | Protocol Compliance | Medication Compliance Percentage
Item
6. ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period.
boolean
C2364293 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C3489773 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
1. severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg)
boolean
C4013784 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Angioedema Drug-induced | Angioedema
Item
2. history of angioedema, drug-related or otherwise
boolean
C0002994 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0002994 (UMLS CUI [2])
Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Aortic coarctation | Primary hyperaldosteronism | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases | Hypertensive disease Drug-induced
Item
3. history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension
boolean
C0155616 (UMLS CUI [1])
C0264649 (UMLS CUI [2])
C0020545 (UMLS CUI [3])
C0856759 (UMLS CUI [4])
C0856760 (UMLS CUI [5])
C0003492 (UMLS CUI [6])
C1384514 (UMLS CUI [7])
C0221406 (UMLS CUI [8])
C0031511 (UMLS CUI [9])
C0022680 (UMLS CUI [10])
C0020538 (UMLS CUI [11,1])
C0458082 (UMLS CUI [11,2])
Transient Ischemic Attack
Item
4. transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke
boolean
C0007787 (UMLS CUI [1])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
5. 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])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol
Item
7. women of child-bearing potential not using highly effective methods of contraception 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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