ID

29357

Description

Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01042392

Link

https://clinicaltrials.gov/show/NCT01042392

Keywords

Versions (1)
  1. 3/20/18 3/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01042392

English

Eligibility Essential Hypertension NCT01042392

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients > 18 years
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
male or female patients. female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
Description

Gender | Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
Description

Essential Hypertension Uncontrolled | Antihypertensive Agent Previous | Intolerance to substance

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C1744706
bp thresholds at visit 1:
Description

Blood Pressure Threshold | Visit First

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0205435
for patients previously treated and uncontrolled: 140≤ office sbp<180 mmhg
Description

Prior Therapy | Patients Uncontrolled | Blood Pressure Threshold | Systolic Pressure Physicians' Office

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0005823
UMLS CUI [3,2]
C0449864
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0031834
for patients previously treated, controlled but intolerant: office sbp≥130 mmhg
Description

Prior Therapy | Patients Controlled | Intolerance to substance | Systolic Pressure Physicians' Office

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2587213
UMLS CUI [3]
C1744706
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0031834
bp thresholds at visit 2 (for all patients):
Description

Blood Pressure Threshold | Visit second

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0205436
160≤office sbp<180 mmhg and
Description

Blood Pressure Threshold | Systolic Pressure Physicians' Office

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0031834
155≤home sbp<175 mmhg (3-day period of home blood pressure monitoring just before randomization)
Description

Blood Pressure Threshold | Systolic Pressure Home | Blood Pressure Monitoring, Home

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0442519
UMLS CUI [3]
C1449681
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child-bearing potential not using any effective methods of contraception
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
severe hypertension (office bp ≥ 180/110 mmhg)
Description

Hypertension, severe | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0005824
impossibility to stop abruptly previous antihypertensive treatments at visit 1
Description

Antihypertensive therapy Discontinue Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
patients previously untreated or patients treated with two or three antihypertensive medications
Description

Patients untreated | Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
history or evidence of a secondary form of hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
history of hypersensitivity to acei or renin inhibitors
Description

Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin-inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0571939
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3653375
history of heart failure, stroke or coronary heart disease
Description

Heart failure | Cerebrovascular accident | Coronary heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0010068
serum potassium ≥ 5.2 mmol/l
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial 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 Essential Hypertension NCT01042392

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients > 18 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
male or female patients. female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Essential Hypertension Uncontrolled | Antihypertensive Agent Previous | Intolerance to substance
Item
patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
boolean
C0085580 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3])
Blood Pressure Threshold | Visit First
Item
bp thresholds at visit 1:
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1512346 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
Prior Therapy | Patients Uncontrolled | Blood Pressure Threshold | Systolic Pressure Physicians' Office
Item
for patients previously treated and uncontrolled: 140≤ office sbp<180 mmhg
boolean
C1514463 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0005823 (UMLS CUI [3,1])
C0449864 (UMLS CUI [3,2])
C0871470 (UMLS CUI [4,1])
C0031834 (UMLS CUI [4,2])
Prior Therapy | Patients Controlled | Intolerance to substance | Systolic Pressure Physicians' Office
Item
for patients previously treated, controlled but intolerant: office sbp≥130 mmhg
boolean
C1514463 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3])
C0871470 (UMLS CUI [4,1])
C0031834 (UMLS CUI [4,2])
Blood Pressure Threshold | Visit second
Item
bp thresholds at visit 2 (for all patients):
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1512346 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Blood Pressure Threshold | Systolic Pressure Physicians' Office
Item
160≤office sbp<180 mmhg and
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0031834 (UMLS CUI [2,2])
Blood Pressure Threshold | Systolic Pressure Home | Blood Pressure Monitoring, Home
Item
155≤home sbp<175 mmhg (3-day period of home blood pressure monitoring just before randomization)
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0442519 (UMLS CUI [2,2])
C1449681 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Absent
Item
women of child-bearing potential not using any effective methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hypertension, severe | Blood pressure determination
Item
severe hypertension (office bp ≥ 180/110 mmhg)
boolean
C4013784 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Antihypertensive therapy Discontinue Unsuccessful
Item
impossibility to stop abruptly previous antihypertensive treatments at visit 1
boolean
C0585941 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Patients untreated | Antihypertensive Agents Quantity
Item
patients previously untreated or patients treated with two or three antihypertensive medications
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin-inhibitors
Item
history of hypersensitivity to acei or renin inhibitors
boolean
C0571939 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C3653375 (UMLS CUI [2,2])
Heart failure | Cerebrovascular accident | Coronary heart disease
Item
history of heart failure, stroke or coronary heart disease
boolean
C0018801 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
Serum potassium measurement
Item
serum potassium ≥ 5.2 mmol/l
boolean
C0302353 (UMLS CUI [1])
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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