ID

29958

Description

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00778921

Link

https://clinicaltrials.gov/show/NCT00778921

Keywords

Versions (1)
  1. 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 NCT00778921

English

Eligibility Hypertension NCT00778921

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 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 5 (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
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
pre-menopausal women not taking accepted form of birth control
Description

Premenopausal state Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
history of cardiovascular conditions
Description

Cardiovascular conditions

Data type

boolean

Alias
UMLS CUI [1]
C2015790
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
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 NCT00778921

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 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 5 (randomization)
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])
Premenopausal state Contraceptive methods Absent
Item
pre-menopausal women not taking accepted form of birth control
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Serum potassium measurement
Item
serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1
boolean
C0302353 (UMLS CUI [1])
Cardiovascular conditions
Item
history of cardiovascular conditions
boolean
C2015790 (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])
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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