ID

39960

Description

Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01193101

Link

https://clinicaltrials.gov/show/NCT01193101

Keywords

Versions (1)
  1. 3/6/20 3/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01193101

English

Eligibility Hypertension NCT01193101

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must give written informed consent before any assessment is performed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmhg and < 110 mmhg, and mean sitting systolic blood pressure ≥ 140 mmhg and < 180 mmhg).
Description

Essential Hypertension Mild Untreated | Essential Hypertension Moderate Untreated | Essential Hypertension Mild | Essential Hypertension Moderate | Antihypertensive therapy | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C0085580
UMLS CUI [3,2]
C2945599
UMLS CUI [4,1]
C0085580
UMLS CUI [4,2]
C0205081
UMLS CUI [5]
C0585941
UMLS CUI [6,1]
C1319894
UMLS CUI [6,2]
C0444504
UMLS CUI [7,1]
C1319893
UMLS CUI [7,2]
C0444504
3. patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
Description

Ambulatory Blood Pressure Monitoring Time Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C1948053
4. patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.
Description

Able to communicate | Protocol Compliance | Medication Compliance

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with severe hypertension.
Description

Hypertension, severe

Data type

boolean

Alias
UMLS CUI [1]
C4013784
2. patients with 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. pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. women of child-bearing potential , who do not use adequate birth control methods
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
5. history or evidence of a secondary form of hypertension.
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
6. history of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, tia, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
Description

Angina Pectoris | Myocardial Infarction | Coronary Artery Bypass Surgery | Myocardial Ischemia | Surgery Arterial | Intervention Arterial Percutaneous | Cerebrovascular accident | Transient Ischemic Attack | Carotid Stenosis | Aortic Aneurysm | Peripheral Arterial Disease

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0151744
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0221464
UMLS CUI [6,1]
C0184661
UMLS CUI [6,2]
C0221464
UMLS CUI [6,3]
C0522523
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007787
UMLS CUI [9]
C0007282
UMLS CUI [10]
C0003486
UMLS CUI [11]
C1704436
7. diabetes mellitus.
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
8. previous or current diagnosis of heart failure (nyha class ii-iv).
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
9. clinically significant valvular heart disease at the time of screening.
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
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 NCT01193101

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. patients must give written informed consent before any assessment is performed.
boolean
C0021430 (UMLS CUI [1])
Essential Hypertension Mild Untreated | Essential Hypertension Moderate Untreated | Essential Hypertension Mild | Essential Hypertension Moderate | Antihypertensive therapy | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
2. patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmhg and < 110 mmhg, and mean sitting systolic blood pressure ≥ 140 mmhg and < 180 mmhg).
boolean
C0085580 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0085580 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0085580 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0085580 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C0585941 (UMLS CUI [5])
C1319894 (UMLS CUI [6,1])
C0444504 (UMLS CUI [6,2])
C1319893 (UMLS CUI [7,1])
C0444504 (UMLS CUI [7,2])
Ambulatory Blood Pressure Monitoring Time Period
Item
3. patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
boolean
C0242876 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Able to communicate | Protocol Compliance | Medication Compliance
Item
4. patient 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])
C3489773 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
1. patients with severe hypertension.
boolean
C4013784 (UMLS CUI [1])
Angioedema Drug-induced | Angioedema
Item
2. patients with history of angioedema, drug-related or otherwise
boolean
C0002994 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0002994 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
3. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
4. women of child-bearing potential , who do not use adequate birth control methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Secondary hypertension
Item
5. history or evidence of a secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Angina Pectoris | Myocardial Infarction | Coronary Artery Bypass Surgery | Myocardial Ischemia | Surgery Arterial | Intervention Arterial Percutaneous | Cerebrovascular accident | Transient Ischemic Attack | Carotid Stenosis | Aortic Aneurysm | Peripheral Arterial Disease
Item
6. history of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, tia, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
boolean
C0002962 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0543467 (UMLS CUI [5,1])
C0221464 (UMLS CUI [5,2])
C0184661 (UMLS CUI [6,1])
C0221464 (UMLS CUI [6,2])
C0522523 (UMLS CUI [6,3])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0007282 (UMLS CUI [9])
C0003486 (UMLS CUI [10])
C1704436 (UMLS CUI [11])
Diabetes Mellitus
Item
7. diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
8. 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
9. clinically significant valvular heart disease at the time of screening.
boolean
C0018824 (UMLS CUI [1])
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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