ID

40047

Beschrijving

Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT01541189

Link

https://clinicaltrials.gov/show/NCT01541189

Trefwoorden

Versies (1)
  1. 10-03-20 10-03-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 maart 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hypertension NCT01541189

Engels

Eligibility Hypertension NCT01541189

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
Beschrijving

Essential Hypertension | Therapy naive | Antihypertensive therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0919936
UMLS CUI [3]
C0585941
all treatment-naive patients need to have 140mmhg≤mssbp<180mmhg and 90mmhg≤msdbp< 110mmhg at visit 1
Beschrijving

Therapy naive | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
for patients on mono antihypertensive therapy, mssbp/msdbp should <160/100mmhg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have mssbp≥140 mmhg and <180mmhg and msdbp≥90 mmhg and <110mmhg
Beschrijving

Antihypertensive therapy | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Time Period Screening | Time Period Therapeutic

Datatype

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C1948053
UMLS CUI [4,2]
C1710032
UMLS CUI [5,1]
C1948053
UMLS CUI [5,2]
C0302350
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Beschrijving

Hypertension, severe

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
malignant hypertension
Beschrijving

Malignant Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0020540
secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
renal dysfunction(serum creatinine > 2.0mg(176.8μmol/l)at visit 1)
Beschrijving

Renal dysfunction | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
hepatic disease
Beschrijving

Liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
history of hypertensive encephalopathy or cerebrovascular accident within 6 months
Beschrijving

Hypertensive Encephalopathy | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
history of myocardial infarction, coronary revascularization within 6 months
Beschrijving

Myocardial Infarction | Coronary revascularisation

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0877341
type 1 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
patietns with hba1c >8% at visit 1
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
women in pregnancy and lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
potentially fertile female patients not using effective contraceptive methods
Beschrijving

Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
be allergy to study drug.
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
other protocol defined inclusion/exlusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Terug naar het begin van de pagina

Similar models

Eligibility Hypertension NCT01541189

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Therapy naive | Antihypertensive therapy
Item
naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
boolean
C0085580 (UMLS CUI [1])
C0919936 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
Therapy naive | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
all treatment-naive patients need to have 140mmhg≤mssbp<180mmhg and 90mmhg≤msdbp< 110mmhg at visit 1
boolean
C0919936 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Antihypertensive therapy | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Time Period Screening | Time Period Therapeutic
Item
for patients on mono antihypertensive therapy, mssbp/msdbp should <160/100mmhg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have mssbp≥140 mmhg and <180mmhg and msdbp≥90 mmhg and <110mmhg
boolean
C0585941 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1948053 (UMLS CUI [4,1])
C1710032 (UMLS CUI [4,2])
C1948053 (UMLS CUI [5,1])
C0302350 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Renal dysfunction | Creatinine measurement, serum
Item
renal dysfunction(serum creatinine > 2.0mg(176.8μmol/l)at visit 1)
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver disease
Item
hepatic disease
boolean
C0023895 (UMLS CUI [1])
Hypertensive Encephalopathy | Cerebrovascular accident
Item
history of hypertensive encephalopathy or cerebrovascular accident within 6 months
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Myocardial Infarction | Coronary revascularisation
Item
history of myocardial infarction, coronary revascularization within 6 months
boolean
C0027051 (UMLS CUI [1])
C0877341 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
patietns with hba1c >8% at visit 1
boolean
C0474680 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women in pregnancy and lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
potentially fertile female patients not using effective contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
be allergy to study drug.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exlusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial