ID

29886

Beskrivning

Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00424541

Länk

https://clinicaltrials.gov/show/NCT00424541

Nyckelord

Versioner (1)
  1. 2018-04-25 2018-04-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT00424541

Engelsk

Eligibility Hypertension NCT00424541

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
japanese patients with mild to moderate essential hypertension aged 20 to 80 years
Beskrivning

Japanese | Essential Hypertension Mild | Essential Hypertension Moderate | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0085580
UMLS CUI [3,2]
C0205081
UMLS CUI [4]
C0001779
blood pressure: mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:
Beskrivning

Blood Pressure | Sitting diastolic blood pressure mean pre treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C2709094
14 days before treatment: ≥ 90 mmhg and < 110 mmhg
Beskrivning

Days Number pre treatment | Sitting diastolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C2709094
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
3 days before treatment: ≥ 95 mmhg and < 110 mmhg
Beskrivning

Days Number pre treatment | Sitting diastolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C2709094
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
the difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmhg
Beskrivning

Difference Result | Sitting diastolic blood pressure mean pre treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705242
UMLS CUI [1,2]
C1274040
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C2709094
body weight no less than 50 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmhg and/or mean diastolic blood pressure ≥ 110 mmhg at day -28, day-14 and day -3.
Beskrivning

Systolic Pressure mean | Diastolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0444504
patients with or suspected of having secondary hypertension
Beskrivning

Secondary hypertension | Secondary hypertension Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
patients suspected of having malignant hypertension
Beskrivning

Malignant Hypertension Suspected | Malignant Hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020540
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0020540
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

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

Eligibility Hypertension NCT00424541

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Essential Hypertension Mild | Essential Hypertension Moderate | Age
Item
japanese patients with mild to moderate essential hypertension aged 20 to 80 years
boolean
C1556094 (UMLS CUI [1])
C0085580 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0085580 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Blood Pressure | Sitting diastolic blood pressure mean pre treatment
Item
blood pressure: mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:
boolean
C0005823 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C2709094 (UMLS CUI [2,3])
Days Number pre treatment | Sitting diastolic blood pressure mean
Item
14 days before treatment: ≥ 90 mmhg and < 110 mmhg
boolean
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Days Number pre treatment | Sitting diastolic blood pressure mean
Item
3 days before treatment: ≥ 95 mmhg and < 110 mmhg
boolean
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Difference Result | Sitting diastolic blood pressure mean pre treatment
Item
the difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmhg
boolean
C1705242 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C2709094 (UMLS CUI [2,3])
Body Weight
Item
body weight no less than 50 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure mean | Diastolic blood pressure mean
Item
patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmhg and/or mean diastolic blood pressure ≥ 110 mmhg at day -28, day-14 and day -3.
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Secondary hypertension | Secondary hypertension Suspected
Item
patients with or suspected of having secondary hypertension
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Malignant Hypertension Suspected | Malignant Hypertension
Item
patients suspected of having malignant hypertension
boolean
C0020540 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0020540 (UMLS CUI [2])
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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