ID

35860

Description

Study of Efficacy and Safety of CVAA489 in Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02062645

Link

https://clinicaltrials.gov/show/NCT02062645

Keywords

Versions (1)
  1. 3/29/19 3/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT02062645

English

Eligibility Essential Hypertension NCT02062645

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, above 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of essential hypertension
Description

Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0085580
newly diagnosed,
Description

Newly Diagnosed

Data type

boolean

Alias
UMLS CUI [1]
C1518321
previously untreated, or currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
Description

Untreated | Antihypertensive therapy Regular Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0332155
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0205272
UMLS CUI [2,3]
C0332268
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected secondary hypertension
Description

Secondary hypertension | Secondary hypertension Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
egfr lower than 30 ml/min
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
Description

Hypertension treatment Other | Patient need for Hypertension treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0578998
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0578998
history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Valsartan | Amlodipine allergy | Hydrochlorothiazide allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348205
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0216784
UMLS CUI [4]
C0570921
UMLS CUI [5]
C0571898
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Description

Malignant Neoplasms Organ system | Exception Basal cell carcinoma Localized Treated | Exception Basal cell carcinoma Localized Untreated | Independent of Local Neoplasm Recurrence | Independent of Neoplasm Metastasis Local

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0460002
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0392752
UMLS CUI [2,4]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C0392752
UMLS CUI [3,4]
C0332155
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0027643
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0027627
UMLS CUI [5,3]
C0205276
use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected pd effect has returned to baseline, whichever is longer.pregnant or nursing (lactating) women
Description

Investigational New Drugs | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
other protocol-defined inclusion/exclusion 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 Essential Hypertension NCT02062645

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, above 18 years of age
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension
Item
diagnosis of essential hypertension
boolean
C0085580 (UMLS CUI [1])
Newly Diagnosed
Item
newly diagnosed,
boolean
C1518321 (UMLS CUI [1])
Untreated | Antihypertensive therapy Regular Lacking
Item
previously untreated, or currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
boolean
C0332155 (UMLS CUI [1])
C0585941 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Secondary hypertension Suspected
Item
known or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Estimated Glomerular Filtration Rate
Item
egfr lower than 30 ml/min
boolean
C3811844 (UMLS CUI [1])
Hypertension treatment Other | Patient need for Hypertension treatment
Item
use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
boolean
C0578998 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0578998 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Valsartan | Amlodipine allergy | Hydrochlorothiazide allergy
Item
history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0216784 (UMLS CUI [3,2])
C0570921 (UMLS CUI [4])
C0571898 (UMLS CUI [5])
Malignant Neoplasms Organ system | Exception Basal cell carcinoma Localized Treated | Exception Basal cell carcinoma Localized Untreated | Independent of Local Neoplasm Recurrence | Independent of Neoplasm Metastasis Local
Item
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C0332155 (UMLS CUI [3,4])
C0332291 (UMLS CUI [4,1])
C0027643 (UMLS CUI [4,2])
C0332291 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C0205276 (UMLS CUI [5,3])
Investigational New Drugs | Pregnancy | Breast Feeding
Item
use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected pd effect has returned to baseline, whichever is longer.pregnant or nursing (lactating) women
boolean
C0013230 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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