ID

29945

Description

Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00739973

Link

https://clinicaltrials.gov/show/NCT00739973

Keywords

Versions (1)
  1. 4/29/18 4/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00739973

English

Eligibility Hypertension NCT00739973

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
msdbp ≥ 90 mmhg and < 110 mmhg at the visit prior to visit 3 (visit 2 or optional visit 201)
Description

Sitting diastolic blood pressure mean Visit Number

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C1549755
msdbp ≥ 95 mmhg and < 110 mmhg at visit 3 (day 1 / randomization).
Description

Sitting diastolic blood pressure mean Visit Number

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C1549755
all patients must have an absolute difference of ≤ 10 mmhg in their msdbp during the last 2 visits of the single-blind run-in period (visit 2 and 3 or visits 201 and 3).
Description

Sitting diastolic blood pressure mean | Difference During Clinic Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0008952
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Description

Hypertension, severe

Data type

boolean

Alias
UMLS CUI [1]
C4013784
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 (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

DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED

Data type

boolean

Alias
UMLS CUI [1]
C0743113
UMLS CUI [2]
C0743118
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 malignancy within 5 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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
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Similar models

Eligibility Hypertension NCT00739973

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Sitting diastolic blood pressure mean Visit Number
Item
msdbp ≥ 90 mmhg and < 110 mmhg at the visit prior to visit 3 (visit 2 or optional visit 201)
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1549755 (UMLS CUI [1,3])
Sitting diastolic blood pressure mean Visit Number
Item
msdbp ≥ 95 mmhg and < 110 mmhg at visit 3 (day 1 / randomization).
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1549755 (UMLS CUI [1,3])
Sitting diastolic blood pressure mean | Difference During Clinic Visits
Item
all patients must have an absolute difference of ≤ 10 mmhg in their msdbp during the last 2 visits of the single-blind run-in period (visit 2 and 3 or visits 201 and 3).
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1705242 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
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 (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])
DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
Item
uncontrolled type 1 or type 2 diabetes mellitus
boolean
C0743113 (UMLS CUI [1])
C0743118 (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])
Malignant Neoplasms
Item
history of malignancy within 5 years
boolean
C0006826 (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, 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])
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