ID

30827

Description

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

Keywords

Versions (1)
  1. 6/25/18 6/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Moderate to Severe Hypertension NCT00841672

English

Eligibility Moderate to Severe Hypertension NCT00841672

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients ≥ 18 years of age
Description

Outpatients | Age

Data type

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
Description

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

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
mild to moderate hypertension
Description

Hypertension, mild | Hypertension, moderate

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Childbearing Potential

Data type

boolean

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

Heart failure New York Heart Association Classification

Data type

boolean

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

Serum potassium measurement

Data type

boolean

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

Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

Antihypertensive Agents Quantity Combination

Data type

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
Description

Eligibility Criteria Study Protocol

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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