ID

29886

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00424541

Stichworte

Versionen (1)
  1. 25.04.18 25.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hypertension NCT00424541

Englisch

Eligibility Hypertension NCT00424541

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Japanese | Essential Hypertension Mild | Essential Hypertension Moderate | Age

Datentyp

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:
Beschreibung

Blood Pressure | Sitting diastolic blood pressure mean pre treatment

Datentyp

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
Beschreibung

Days Number pre treatment | Sitting diastolic blood pressure mean

Datentyp

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
Beschreibung

Days Number pre treatment | Sitting diastolic blood pressure mean

Datentyp

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
Beschreibung

Difference Result | Sitting diastolic blood pressure mean pre treatment

Datentyp

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
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beschreibung

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.
Beschreibung

Systolic Pressure mean | Diastolic blood pressure mean

Datentyp

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
Beschreibung

Secondary hypertension | Secondary hypertension Suspected

Datentyp

boolean

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

Malignant Hypertension Suspected | Malignant Hypertension

Datentyp

boolean

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

Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hypertension NCT00424541

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video