ID

30827

Beschrijving

Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00841672

Link

https://clinicaltrials.gov/show/NCT00841672

Trefwoorden

Versies (1)
  1. 25-06-18 25-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Moderate to Severe Hypertension NCT00841672

Engels

Eligibility Moderate to Severe Hypertension NCT00841672

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients ≥ 18 years of age
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with a diagnosis of moderate to severe hypertension, defined as mssbp ≥ 160 mmhg and < 200 mmhg at visit 2
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C1969581
UMLS CUI [2]
C4013784
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mild to moderate hypertension
Beschrijving

Hypertension, mild | Hypertension, moderate

Datatype

boolean

Alias
UMLS CUI [1]
C3276943
UMLS CUI [2]
C1969581
pregnant or nursing (lactating) women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child-bearing potential
Beschrijving

Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
previous or current diagnosis of heart failure new york heart association(nyha) class ii-iv.
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1.
Beschrijving

Serum potassium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0302353
uncontrolled type 1 or type 2 diabetes mellitus
Beschrijving

Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C2732402
UMLS CUI [2]
C2733146
hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
Beschrijving

Hypersensitivity Renin-inhibitors | Calcium-channel blocker allergy | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3653375
UMLS CUI [2]
C0570913
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0220807
UMLS CUI [3,4]
C2348205
history of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (tia), 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
patients on a combination of 3 or more antihypertensive medications
Beschrijving

Antihypertensive Agents Quantity Combination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205195
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

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

Eligibility Moderate to Severe Hypertension NCT00841672

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients ≥ 18 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertension, moderate | Hypertension, severe | Sitting systolic blood pressure mean
Item
patients with a diagnosis of moderate to severe hypertension, defined as mssbp ≥ 160 mmhg and < 200 mmhg at visit 2
boolean
C1969581 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, mild | Hypertension, moderate
Item
mild to moderate hypertension
boolean
C3276943 (UMLS CUI [1])
C1969581 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential
Item
women of child-bearing potential
boolean
C3831118 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
previous or current diagnosis of heart failure new york heart association(nyha) class ii-iv.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Serum potassium measurement
Item
serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1.
boolean
C0302353 (UMLS CUI [1])
Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled
Item
uncontrolled type 1 or type 2 diabetes mellitus
boolean
C2732402 (UMLS CUI [1])
C2733146 (UMLS CUI [2])
Hypersensitivity Renin-inhibitors | Calcium-channel blocker allergy | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
boolean
C0020517 (UMLS CUI [1,1])
C3653375 (UMLS CUI [1,2])
C0570913 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0220807 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (tia), 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])
Antihypertensive Agents Quantity Combination
Item
patients on a combination of 3 or more antihypertensive medications
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
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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