ID

39249

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02058446

Nyckelord

Versioner (1)
  1. 2019-12-12 2019-12-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT02058446

Engelsk

Eligibility Essential Hypertension NCT02058446

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Essential Hypertension | Diastolic blood pressure | Systolic Pressure

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Protocol Compliance

Datatyp

boolean

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

Comprehension Study Protocol | Informed Consent

Datatyp

boolean

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

Exclusion Criteria

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

Condition Specified Any

Datatyp

boolean

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

Malignant Hypertension

Datatyp

boolean

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

Secondary hypertension

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Hypertensive Encephalopathy | Cerebrovascular accident

Datatyp

boolean

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

Cerebrovascular accident | Myocardial Infarction | Revascularization Type Any

Datatyp

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
Beskrivning

Congestive heart failure New York Heart Association Classification

Datatyp

boolean

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

Second degree atrioventricular block | Complete atrioventricular block

Datatyp

boolean

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

Angina Pectoris

Datatyp

boolean

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

Cardiac Arrhythmia | Heart valve disease

Datatyp

boolean

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

Pancreatic Disease | Liver disease | Kidney Disease

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

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
Beskrivning

Females & males of reproductive potential Contraceptive methods Unwilling

Datatyp

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
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

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

Eligibility Essential Hypertension NCT02058446

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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