ID

29967

Beschrijving

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00797862

Link

https://clinicaltrials.gov/show/NCT00797862

Trefwoorden

Versies (1)
  1. 30-04-18 30-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00797862

Engels

Eligibility Hypertension NCT00797862

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients ≥ 18 years of age
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
participants with essential hypertension:
Beschrijving

Essential Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
naive participants must have a mean sitting systolic blood pressure (mssbp) ≥
Beschrijving

Study Subject Therapy naive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0919936
150 mmhg and < 180 mmhg at visit 1 and visit 2. (participants are considered
Beschrijving

Sitting systolic blood pressure mean Visit Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C1549755
'naïve' if they have never been treated with any antihypertensive medication.)
Beschrijving

Antihypertensive Agents Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
all participants must have a mssbp ≥ 150 mmhg and < 180 mmhg at visit 2
Beschrijving

Study Subject All | Sitting systolic blood pressure mean Visit Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C1549755
written informed consent to participate in this study prior to any study procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Beschrijving

Hypertension, severe

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
pregnant or nursing (lactating) women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pre-menopausal women not taking accepted form of birth control
Beschrijving

Premenopausal state Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
serum potassium ≥ 5.5 meq/l (mmol/l) at visit 1
Beschrijving

Serum potassium measurement

Datatype

boolean

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

Cardiovascular conditions

Datatype

boolean

Alias
UMLS CUI [1]
C2015790
uncontrolled type 1 or type 2 diabetes mellitus
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0743113
UMLS CUI [2]
C0743118
hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
Beschrijving

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

Datatype

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.
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT00797862

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male or female outpatients ≥ 18 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential Hypertension
Item
participants with essential hypertension:
boolean
C0085580 (UMLS CUI [1])
Study Subject Therapy naive
Item
naive participants must have a mean sitting systolic blood pressure (mssbp) ≥
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Sitting systolic blood pressure mean Visit Number
Item
150 mmhg and < 180 mmhg at visit 1 and visit 2. (participants are considered
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1549755 (UMLS CUI [1,3])
Antihypertensive Agents Absent
Item
'naïve' if they have never been treated with any antihypertensive medication.)
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Study Subject All | Sitting systolic blood pressure mean Visit Number
Item
all participants must have a mssbp ≥ 150 mmhg and < 180 mmhg at visit 2
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1549755 (UMLS CUI [2,3])
Informed Consent
Item
written informed consent to participate in this study prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
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 ≥ 5.5 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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