ID

36108

Description

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

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hypertension NCT01865188

English

Eligibility Hypertension NCT01865188

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female outpatients
Description

Outpatients

Data type

boolean

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

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

Data type

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.
Description

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

Data type

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.
Description

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

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]
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.
Description

Difference Sitting systolic blood pressure mean | Randomization Visit | 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]
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.
Description

Able to communicate | Protocol Compliance | Medication Compliance Percentage

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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
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 | Primary hyperaldosteronism | 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

Data type

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
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. pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

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
Description

Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol

Data type

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
Back to the top of the page

Similar models

Eligibility Hypertension NCT01865188

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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