ID

40121

Description

Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01692301

Link

https://clinicaltrials.gov/show/NCT01692301

Keywords

Versions (1)
  1. 3/12/20 3/12/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 12, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01692301

English

Eligibility Hypertension NCT01692301

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients ≥ 60 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with essential hypertension, untreated or currently taking antihypertensive therapy.
Description

Essential Hypertension Untreated | Essential Hypertension | Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0085580
UMLS CUI [3]
C0585941
3. untreated patients must have an office mssbp ≥150 mmhg and <180 mmhg at visit 101 and visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to visit 1.
Description

Patients untreated | Sitting systolic blood pressure mean | Hypertensive disease Newly Diagnosed | Antihypertensive Agents Absent

Data type

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]
C0020538
UMLS CUI [3,2]
C1518321
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0332197
4. treated patients must have an office mssbp ≥140 mmhg and <180 mmhg at visit 102 (or visit 103) and mssbp ≥150 mmhg and <180 mmhg at visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to visit 1.
Description

Patients Treated | Sitting systolic blood pressure mean | Visit Number | Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1512346
UMLS CUI [3,2]
C0237753
UMLS CUI [4]
C0585941
5. all patients must have pulse pressure >60 mmhg at visit 201. pulse pressure is defined as mssbp- msdbp.
Description

Pulse Pressure Result | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0949236
UMLS CUI [1,2]
C1274040
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
6. patients must have a difference in mssbp within +/-15 mmhg between visit 201 (randomization) and the visit immediately prior to visit 201.
Description

Difference Sitting systolic blood pressure mean | Visit Number | Visit preceding

Data type

boolean

Alias
UMLS CUI [1,1]
C1705242
UMLS CUI [1,2]
C1319893
UMLS CUI [1,3]
C0444504
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0237753
UMLS CUI [3,1]
C1512346
UMLS CUI [3,2]
C0332152
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. malignant or severe hypertension (grade 3 of who classification; msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg)
Description

Malignant Hypertension | Severe Hypertension Grade WHO classification | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0020540
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C4267671
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C1319893
UMLS CUI [4,2]
C0444504
2. history of angioedema, drug-related or otherwise.
Description

Angioedema Drug-induced | Angioedema

Data type

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.
Description

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

Data type

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.
Description

Transient Ischemic Attack | Cerebrovascular accident

Data type

boolean

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

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
6. history of atrial fibrillation or atrial flutter during the 3 months prior to visit 1, or active atrial fibrillation or atrial flutter on the ecg at screening.
Description

Atrial Fibrillation | Atrial Flutter | Atrial Fibrillation by ECG | Atrial Flutter by ECG

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
UMLS CUI [3]
C0344434
UMLS CUI [4]
C0344423
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT01692301

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male and female patients ≥ 60 years of age.
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension Untreated | Essential Hypertension | Antihypertensive therapy
Item
2. patients with essential hypertension, untreated or currently taking antihypertensive therapy.
boolean
C0085580 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
Patients untreated | Sitting systolic blood pressure mean | Hypertensive disease Newly Diagnosed | Antihypertensive Agents Absent
Item
3. untreated patients must have an office mssbp ≥150 mmhg and <180 mmhg at visit 101 and visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to visit 1.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3,1])
C1518321 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Patients Treated | Sitting systolic blood pressure mean | Visit Number | Antihypertensive therapy
Item
4. treated patients must have an office mssbp ≥140 mmhg and <180 mmhg at visit 102 (or visit 103) and mssbp ≥150 mmhg and <180 mmhg at visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to visit 1.
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1512346 (UMLS CUI [3,1])
C0237753 (UMLS CUI [3,2])
C0585941 (UMLS CUI [4])
Pulse Pressure Result | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
5. all patients must have pulse pressure >60 mmhg at visit 201. pulse pressure is defined as mssbp- msdbp.
boolean
C0949236 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Difference Sitting systolic blood pressure mean | Visit Number | Visit preceding
Item
6. patients must have a difference in mssbp within +/-15 mmhg between visit 201 (randomization) and the visit immediately prior to visit 201.
boolean
C1705242 (UMLS CUI [1,1])
C1319893 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C1512346 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C1512346 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Malignant Hypertension | Severe Hypertension Grade WHO classification | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
1. malignant or severe hypertension (grade 3 of who classification; msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg)
boolean
C0020540 (UMLS CUI [1])
C4013784 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C4267671 (UMLS CUI [2,3])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
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 | Conn Syndrome | 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 | Cerebrovascular accident
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])
C0038454 (UMLS CUI [2])
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])
Atrial Fibrillation | Atrial Flutter | Atrial Fibrillation by ECG | Atrial Flutter by ECG
Item
6. history of atrial fibrillation or atrial flutter during the 3 months prior to visit 1, or active atrial fibrillation or atrial flutter on the ecg at screening.
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
C0344434 (UMLS CUI [3])
C0344423 (UMLS CUI [4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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