ID

29357

Beschreibung

Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01042392

Link

https://clinicaltrials.gov/show/NCT01042392

Stichworte

Versionen (1)
  1. 20.03.18 20.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. März 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 Essential Hypertension NCT01042392

Englisch

Eligibility Essential Hypertension NCT01042392

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients > 18 years
Beschreibung

Outpatients | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
male or female patients. female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
Beschreibung

Gender | Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
Beschreibung

Essential Hypertension Uncontrolled | Antihypertensive Agent Previous | Intolerance to substance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C1744706
bp thresholds at visit 1:
Beschreibung

Blood Pressure Threshold | Visit First

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0205435
for patients previously treated and uncontrolled: 140≤ office sbp<180 mmhg
Beschreibung

Prior Therapy | Patients Uncontrolled | Blood Pressure Threshold | Systolic Pressure Physicians' Office

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0005823
UMLS CUI [3,2]
C0449864
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0031834
for patients previously treated, controlled but intolerant: office sbp≥130 mmhg
Beschreibung

Prior Therapy | Patients Controlled | Intolerance to substance | Systolic Pressure Physicians' Office

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2587213
UMLS CUI [3]
C1744706
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0031834
bp thresholds at visit 2 (for all patients):
Beschreibung

Blood Pressure Threshold | Visit second

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0205436
160≤office sbp<180 mmhg and
Beschreibung

Blood Pressure Threshold | Systolic Pressure Physicians' Office

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0031834
155≤home sbp<175 mmhg (3-day period of home blood pressure monitoring just before randomization)
Beschreibung

Blood Pressure Threshold | Systolic Pressure Home | Blood Pressure Monitoring, Home

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0449864
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0442519
UMLS CUI [3]
C1449681
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child-bearing potential not using any effective methods of contraception
Beschreibung

Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
severe hypertension (office bp ≥ 180/110 mmhg)
Beschreibung

Hypertension, severe | Blood pressure determination

Datentyp

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0005824
impossibility to stop abruptly previous antihypertensive treatments at visit 1
Beschreibung

Antihypertensive therapy Discontinue Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
patients previously untreated or patients treated with two or three antihypertensive medications
Beschreibung

Patients untreated | Antihypertensive Agents Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
history or evidence of a secondary form of hypertension
Beschreibung

Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
history of hypersensitivity to acei or renin inhibitors
Beschreibung

Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin-inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0571939
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3653375
history of heart failure, stroke or coronary heart disease
Beschreibung

Heart failure | Cerebrovascular accident | Coronary heart disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0010068
serum potassium ≥ 5.2 mmol/l
Beschreibung

Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0302353
other protocol-defined inclusion/exclusion criteria may apply
Beschreibung

Clinical Trial Eligibility Criteria Study Protocol

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Essential Hypertension NCT01042392

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients > 18 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
male or female patients. female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Essential Hypertension Uncontrolled | Antihypertensive Agent Previous | Intolerance to substance
Item
patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
boolean
C0085580 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3])
Blood Pressure Threshold | Visit First
Item
bp thresholds at visit 1:
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1512346 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
Prior Therapy | Patients Uncontrolled | Blood Pressure Threshold | Systolic Pressure Physicians' Office
Item
for patients previously treated and uncontrolled: 140≤ office sbp<180 mmhg
boolean
C1514463 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0005823 (UMLS CUI [3,1])
C0449864 (UMLS CUI [3,2])
C0871470 (UMLS CUI [4,1])
C0031834 (UMLS CUI [4,2])
Prior Therapy | Patients Controlled | Intolerance to substance | Systolic Pressure Physicians' Office
Item
for patients previously treated, controlled but intolerant: office sbp≥130 mmhg
boolean
C1514463 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3])
C0871470 (UMLS CUI [4,1])
C0031834 (UMLS CUI [4,2])
Blood Pressure Threshold | Visit second
Item
bp thresholds at visit 2 (for all patients):
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1512346 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Blood Pressure Threshold | Systolic Pressure Physicians' Office
Item
160≤office sbp<180 mmhg and
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0031834 (UMLS CUI [2,2])
Blood Pressure Threshold | Systolic Pressure Home | Blood Pressure Monitoring, Home
Item
155≤home sbp<175 mmhg (3-day period of home blood pressure monitoring just before randomization)
boolean
C0005823 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0442519 (UMLS CUI [2,2])
C1449681 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Absent
Item
women of child-bearing potential not using any effective methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hypertension, severe | Blood pressure determination
Item
severe hypertension (office bp ≥ 180/110 mmhg)
boolean
C4013784 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Antihypertensive therapy Discontinue Unsuccessful
Item
impossibility to stop abruptly previous antihypertensive treatments at visit 1
boolean
C0585941 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Patients untreated | Antihypertensive Agents Quantity
Item
patients previously untreated or patients treated with two or three antihypertensive medications
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin-inhibitors
Item
history of hypersensitivity to acei or renin inhibitors
boolean
C0571939 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C3653375 (UMLS CUI [2,2])
Heart failure | Cerebrovascular accident | Coronary heart disease
Item
history of heart failure, stroke or coronary heart disease
boolean
C0018801 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
Serum potassium measurement
Item
serum potassium ≥ 5.2 mmol/l
boolean
C0302353 (UMLS CUI [1])
Clinical Trial 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