ID

29950

Beschrijving

Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population; ODM derived from: https://clinicaltrials.gov/show/NCT00760266

Link

https://clinicaltrials.gov/show/NCT00760266

Trefwoorden

Versies (2)
  1. 29-04-18 29-04-18 -
  2. 29-04-18 29-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00760266

Engels

Eligibility Hypertension NCT00760266

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female outpatients, ≥ 55 years old
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
2. patients with essential hypertension
Beschrijving

Essential Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
3. prior to randomization: patients must have an office cuff mean sitting systolic blood pressure ≥ 160 mm hg and < 200 mm hg
Beschrijving

Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
4. patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed
Beschrijving

Study Subject Participation Status eligible | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. office blood pressure measured by cuff (mssbp ≥ 200 mm hg and/or msdbp ≥ 110 mm hg) at visits 1-5
Beschrijving

Blood pressure determination | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
2. history or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
Beschrijving

Secondary hypertension | Etiology Renal Artery Stenosis uncorrected | Etiology Pheochromocytoma

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0035067
UMLS CUI [2,3]
C4072785
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0031511
3. history of hypertensive encephalopathy or heart failure (new york heart association [nyha] class ii-iv)
Beschrijving

Hypertensive Encephalopathy | Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
4. cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) within 1 year prior to visit 1
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0010055
UMLS CUI [5]
C1532338
5. serum sodium less than the lower limit of normal, serum potassium < 3.5 meq/l (corresponding to 3.5 mmol/l) or ≥ 5.3 meq/l (corresponding to 5.3 mmol/l), or dehydration at visit 1.
Beschrijving

Serum sodium concentration below normal | Serum potassium measurement | Dehydration

Datatype

boolean

Alias
UMLS CUI [1]
C4048754
UMLS CUI [2]
C0302353
UMLS CUI [3]
C0011175
6. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (> 5 miu/ml)
Beschrijving

Pregnancy | Breast Feeding | HCG pregnancy test Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0546577
UMLS CUI [3,2]
C1514241
7. use of other investigational drugs within 30 days of enrollment.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
other exclusions may apply.
Beschrijving

Exclusion Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Hypertension NCT00760266

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
1. male or female outpatients, ≥ 55 years old
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential Hypertension
Item
2. patients with essential hypertension
boolean
C0085580 (UMLS CUI [1])
Sitting systolic blood pressure mean
Item
3. prior to randomization: patients must have an office cuff mean sitting systolic blood pressure ≥ 160 mm hg and < 200 mm hg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Study Subject Participation Status eligible | Informed Consent
Item
4. patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Blood pressure determination | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
1. office blood pressure measured by cuff (mssbp ≥ 200 mm hg and/or msdbp ≥ 110 mm hg) at visits 1-5
boolean
C0005824 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Secondary hypertension | Etiology Renal Artery Stenosis uncorrected | Etiology Pheochromocytoma
Item
2. history or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
boolean
C0155616 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0035067 (UMLS CUI [2,2])
C4072785 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0031511 (UMLS CUI [3,2])
Hypertensive Encephalopathy | Heart failure New York Heart Association Classification
Item
3. history of hypertensive encephalopathy or heart failure (new york heart association [nyha] class ii-iv)
boolean
C0151620 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
4. cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) within 1 year prior to visit 1
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C1532338 (UMLS CUI [5])
Serum sodium concentration below normal | Serum potassium measurement | Dehydration
Item
5. serum sodium less than the lower limit of normal, serum potassium < 3.5 meq/l (corresponding to 3.5 mmol/l) or ≥ 5.3 meq/l (corresponding to 5.3 mmol/l), or dehydration at visit 1.
boolean
C4048754 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
C0011175 (UMLS CUI [3])
Pregnancy | Breast Feeding | HCG pregnancy test Positive
Item
6. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (> 5 miu/ml)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0546577 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Investigational New Drugs
Item
7. use of other investigational drugs within 30 days of enrollment.
boolean
C0013230 (UMLS CUI [1])
Exclusion Criteria Additional
Item
other exclusions may apply.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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