ID

21063

Beschrijving

Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00387517

Link

https://clinicaltrials.gov/show/NCT00387517

Trefwoorden

Versies (1)
  1. 06-04-17 06-04-17 -
Geüploaded op

6 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00387517

Engels

Eligibility Hypertension NCT00387517

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients 18 years old or older.
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with a diagnosis of hypertension defined as follows:
Beschrijving

Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp >= mmhg and < 110 mmhg at visit 1.
Beschrijving

Hypertensive disease Newly Diagnosed | Hypertensive disease Untreated | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
all patients who have been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp >= 85 mmhg and < 110 mmhg at visit 2.
Beschrijving

Hypertensive disease Treated | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
all patients must have a msdbp >= 90 mmhg and < 110 mmhg at visit 5.
Beschrijving

Patients All | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0444868
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
patients who are eligible and consent to participate in the study
Beschrijving

Study Subject Participation Status | Informed Consent

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension (msdbp >= 110 mmhg and/or mssbp >=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
previous or current diagnosis of heart failure.
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0010055
UMLS CUI [6]
C1532338
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Clinical Trial Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT00387517

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male or female outpatients 18 years old or older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertensive disease
Item
patients with a diagnosis of hypertension defined as follows:
boolean
C0020538 (UMLS CUI [1])
Hypertensive disease Newly Diagnosed | Hypertensive disease Untreated | Sitting diastolic blood pressure mean
Item
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp >= mmhg and < 110 mmhg at visit 1.
boolean
C0020538 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Hypertensive disease Treated | Sitting diastolic blood pressure mean
Item
all patients who have been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp >= 85 mmhg and < 110 mmhg at visit 2.
boolean
C0020538 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Patients All | Sitting diastolic blood pressure mean
Item
all patients must have a msdbp >= 90 mmhg and < 110 mmhg at visit 5.
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Study Subject Participation Status | Informed Consent
Item
patients who are eligible and consent to participate in the study
boolean
C2348568 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
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])
Heart failure
Item
previous or current diagnosis of heart failure.
boolean
C0018801 (UMLS CUI [1])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
Clinical Trial 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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