ID

40047

Description

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

Keywords

Versions (1)
  1. 3/10/20 3/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01541189

English

Eligibility Hypertension NCT01541189

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Essential Hypertension | Therapy naive | Antihypertensive therapy

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Description

Hypertension, severe

Data type

boolean

Alias
UMLS CUI [1]
C4013784
malignant hypertension
Description

Malignant Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020540
secondary hypertension
Description

Secondary hypertension

Data type

boolean

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

Renal dysfunction | Creatinine measurement, serum

Data type

boolean

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

Liver disease

Data type

boolean

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

Hypertensive Encephalopathy | Cerebrovascular accident

Data type

boolean

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

Myocardial Infarction | Coronary revascularisation

Data type

boolean

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

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

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

Hemoglobin A1c measurement

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Childbearing Potential Contraceptive methods Absent

Data type

boolean

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

Hypersensitivity Investigational New Drugs

Data type

boolean

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

Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Hypertension NCT01541189

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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