ID

39249

Beschrijving

PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02058446

Link

https://clinicaltrials.gov/show/NCT02058446

Trefwoorden

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

See clinicaltrials.gov

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12 december 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT02058446

Engels

Eligibility Essential Hypertension NCT02058446

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are 20-80 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with essential hypertension (90 mmhg ≤ dbp ≤ 110 mmhg and/or 140 mmhg ≤ sbp
Beschrijving

Essential Hypertension | Diastolic blood pressure | Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0871470
≤ 180 mmhg) whose bp is not adequately controlled with amlodipine (or another ccb) alone or with valsartan (or another arb) alone, or with any antihypertensive monotherapy.
Beschrijving

Blood Pressure Poorly controlled | Amlodipine | Calcium Channel Blockers | valsartan | Angiotensin II receptor antagonist | Combined Modality Therapy | Antihypertensive therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0051696
UMLS CUI [3]
C0006684
UMLS CUI [4]
C0216784
UMLS CUI [5]
C0521942
UMLS CUI [6]
C0009429
UMLS CUI [7]
C0585941
agree to and are able to follow the study procedures
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
understand the nature of the study, and have signed informed consent forms
Beschrijving

Comprehension Study Protocol | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any of the following conditions:
Beschrijving

Condition Specified Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1552551
1. malignant (or history of malignant) hypertension
Beschrijving

Malignant Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0020540
2. secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
3. severe hypertension (mean sitting dbp ≥ 110 mmhg and/or mean sitting sbp ≥ 180 mmhg)
Beschrijving

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

Datatype

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
4. a history of hypertensive encephalopathy or cerebrovascular accident
Beschrijving

Hypertensive Encephalopathy | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
5. cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization
Beschrijving

Cerebrovascular accident | Myocardial Infarction | Revascularization Type Any

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0581603
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C1552551
6. new york heart association class iii -iv congestive heart failure
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
7. second- or third-degree heart block
Beschrijving

Second degree atrioventricular block | Complete atrioventricular block

Datatype

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
8. angina pectoris
Beschrijving

Angina Pectoris

Datatype

boolean

Alias
UMLS CUI [1]
C0002962
9. significant arrhythmia or valvular heart disease
Beschrijving

Cardiac Arrhythmia | Heart valve disease

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0018824
10. significant pancreatic, hepatic, or renal disease
Beschrijving

Pancreatic Disease | Liver disease | Kidney Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0030286
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
11. diabetes requiring insulin treatment or poorly controlled type 2 diabetes
Beschrijving

Diabetes Mellitus Requirement Insulin regime | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0557978
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
patients with known contraindication or a history of allergy to ccbs or arbs.
Beschrijving

Medical contraindication Calcium Channel Blockers | Calcium-channel blocker allergy | Medical contraindication Angiotensin II receptor antagonist | Allergy to angiotensin II receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0006684
UMLS CUI [2]
C0570913
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0521942
UMLS CUI [4]
C2585204
female patients who are pregnant or lactating.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study
Beschrijving

Females & males of reproductive potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patients is currently participating in any other clinical trial within 30 days
Beschrijving

Study Subject Participation Status | Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Essential Hypertension NCT02058446

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients who are 20-80 years of age
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension | Diastolic blood pressure | Systolic Pressure
Item
patients with essential hypertension (90 mmhg ≤ dbp ≤ 110 mmhg and/or 140 mmhg ≤ sbp
boolean
C0085580 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Blood Pressure Poorly controlled | Amlodipine | Calcium Channel Blockers | valsartan | Angiotensin II receptor antagonist | Combined Modality Therapy | Antihypertensive therapy
Item
≤ 180 mmhg) whose bp is not adequately controlled with amlodipine (or another ccb) alone or with valsartan (or another arb) alone, or with any antihypertensive monotherapy.
boolean
C0005823 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0051696 (UMLS CUI [2])
C0006684 (UMLS CUI [3])
C0216784 (UMLS CUI [4])
C0521942 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C0585941 (UMLS CUI [7])
Protocol Compliance
Item
agree to and are able to follow the study procedures
boolean
C0525058 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
understand the nature of the study, and have signed informed consent forms
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Condition Specified Any
Item
patients with any of the following conditions:
boolean
C0348080 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Malignant Hypertension
Item
1. malignant (or history of malignant) hypertension
boolean
C0020540 (UMLS CUI [1])
Secondary hypertension
Item
2. secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
3. severe hypertension (mean sitting dbp ≥ 110 mmhg and/or mean sitting sbp ≥ 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])
Hypertensive Encephalopathy | Cerebrovascular accident
Item
4. a history of hypertensive encephalopathy or cerebrovascular accident
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Cerebrovascular accident | Myocardial Infarction | Revascularization Type Any
Item
5. cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0581603 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
Congestive heart failure New York Heart Association Classification
Item
6. new york heart association class iii -iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Second degree atrioventricular block | Complete atrioventricular block
Item
7. second- or third-degree heart block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Angina Pectoris
Item
8. angina pectoris
boolean
C0002962 (UMLS CUI [1])
Cardiac Arrhythmia | Heart valve disease
Item
9. significant arrhythmia or valvular heart disease
boolean
C0003811 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
Pancreatic Disease | Liver disease | Kidney Disease
Item
10. significant pancreatic, hepatic, or renal disease
boolean
C0030286 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
Diabetes Mellitus Requirement Insulin regime | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
11. diabetes requiring insulin treatment or poorly controlled type 2 diabetes
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0557978 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Medical contraindication Calcium Channel Blockers | Calcium-channel blocker allergy | Medical contraindication Angiotensin II receptor antagonist | Allergy to angiotensin II receptor antagonist
Item
patients with known contraindication or a history of allergy to ccbs or arbs.
boolean
C1301624 (UMLS CUI [1,1])
C0006684 (UMLS CUI [1,2])
C0570913 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0521942 (UMLS CUI [3,2])
C2585204 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial
Item
patients is currently participating in any other clinical trial within 30 days
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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