ID

29941

Beschrijving

Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study; ODM derived from: https://clinicaltrials.gov/show/NCT00706134

Link

https://clinicaltrials.gov/show/NCT00706134

Trefwoorden

Versies (1)
  1. 28-04-18 28-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00706134

Engels

Eligibility Hypertension NCT00706134

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients 65 years of age and older.
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
Beschrijving

Study Subject Participation Status eligible | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
at the randomization visit patients must have an office mssbp greater than or equal to 150 mmhg and < 180 mmhg (msdbp <110 mmhg) with a less than or equal to 15 mmhg difference during the last two visits of the single blind run-in period.
Beschrijving

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Difference During Visits

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1705242
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C1512346
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension [office msdbp ≥110 mmhg and/or mean sitting systolic blood pressure (mssbp) ≥ 180 mmhg].
Beschrijving

Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
history or evidence of a secondary form of hypertension.
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
known keith-wagener grade iii or iv hypertensive retinopathy.
Beschrijving

Hypertensive Retinopathy Grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
history of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (tia).
Beschrijving

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
current diagnosis of heart failure (nyha class ii-iv).
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
history of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci).
Beschrijving

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
current angina pectoris requiring pharmacological therapy other than nitrates.
Beschrijving

Angina Pectoris Requirement Pharmacotherapy | Exception Nitrates

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028125
other protocol-defined inclusion/exclusion criteria applied to the study.
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 NCT00706134

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male and female outpatients 65 years of age and older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Study Subject Participation Status eligible | Informed Consent
Item
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Difference During Visits
Item
at the randomization visit patients must have an office mssbp greater than or equal to 150 mmhg and < 180 mmhg (msdbp <110 mmhg) with a less than or equal to 15 mmhg difference during the last two visits of the single blind run-in period.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1705242 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C1512346 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
severe hypertension [office msdbp ≥110 mmhg and/or mean sitting systolic blood pressure (mssbp) ≥ 180 mmhg].
boolean
C4013784 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Hypertensive Retinopathy Grade
Item
known keith-wagener grade iii or iv hypertensive retinopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack
Item
history of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (tia).
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (nyha class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci).
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Angina Pectoris Requirement Pharmacotherapy | Exception Nitrates
Item
current angina pectoris requiring pharmacological therapy other than nitrates.
boolean
C0002962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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