ID

29957

Description

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00777946

Link

https://clinicaltrials.gov/show/NCT00777946

Keywords

Versions (2)
  1. 4/30/18 4/30/18 -
  2. 4/30/18 4/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00777946

English

Eligibility Hypertension NCT00777946

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a mean sitting diastolic blood pressure (msdbp) ≥ 95 mmhg and < 110 mmhg at visits 1 and 2
Description

Patients Newly Diagnosed | Hypertensive disease untreated | Sitting diastolic blood pressure mean Visit Number

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
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
UMLS CUI [3,3]
C1549755
patients who have been treated for hypertension within the 4 weeks prior to - visit 1 must have a msdbp ≥ 90 mmhg and < 110 mmhg at visit 2
Description

Therapeutic procedure Hypertensive disease | Sitting diastolic blood pressure mean Visit Number

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C1549755
all patients must have a msdbp ≥ 90 mmhg and < 110 mmhg at visit 4
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
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 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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1960108
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
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 Hypertension NCT00777946

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Newly Diagnosed | Hypertensive disease untreated | Sitting diastolic blood pressure mean Visit Number
Item
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a mean sitting diastolic blood pressure (msdbp) ≥ 95 mmhg and < 110 mmhg at visits 1 and 2
boolean
C0030705 (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])
C1549755 (UMLS CUI [3,3])
Therapeutic procedure Hypertensive disease | Sitting diastolic blood pressure mean Visit Number
Item
patients who have been treated for hypertension within the 4 weeks prior to - visit 1 must have a msdbp ≥ 90 mmhg and < 110 mmhg at visit 2
boolean
C0087111 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1549755 (UMLS CUI [2,3])
Sitting diastolic blood pressure mean Visit Number
Item
all patients must have a msdbp ≥ 90 mmhg and < 110 mmhg at visit 4
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1549755 (UMLS CUI [1,3])
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 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])
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 inhibitor | 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])
C1960108 (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])
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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