ID

29886

Description

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

Lien

https://clinicaltrials.gov/show/NCT00424541

Mots-clés

Versions (1)
  1. 25/04/18 25/04/18 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

25 aprile 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Hypertension NCT00424541

Anglais

Eligibility Hypertension NCT00424541

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Japanese | Essential Hypertension Mild | Essential Hypertension Moderate | Age

Type de données

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:
Description

Blood Pressure | Sitting diastolic blood pressure mean pre treatment

Type de données

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
Description

Days Number pre treatment | Sitting diastolic blood pressure mean

Type de données

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
Description

Days Number pre treatment | Sitting diastolic blood pressure mean

Type de données

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
Description

Difference Result | Sitting diastolic blood pressure mean pre treatment

Type de données

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
Description

Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

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.
Description

Systolic Pressure mean | Diastolic blood pressure mean

Type de données

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
Description

Secondary hypertension | Secondary hypertension Suspected

Type de données

boolean

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

Malignant Hypertension Suspected | Malignant Hypertension

Type de données

boolean

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

Eligibility Criteria Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Retour au début de la page

Similar models

Eligibility Hypertension NCT00424541

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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