ID

40507

Descrição

SER100 in Isolated Systolic Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01987284

Link

https://clinicaltrials.gov/show/NCT01987284

Palavras-chave

Versões (1)
  1. 28/04/2020 28/04/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de abril de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Isolated Systolic Hypertension NCT01987284

Inglês

Eligibility Isolated Systolic Hypertension NCT01987284

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
mean systolic blood pressure ≥ 150 mmhg and mean diastolic blood pressure < 90 mmhg -
Descrição

Systolic Pressure mean | Diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0444504
as determined by daytime continuous ambulatory blood pressure measurement (abpm)
Descrição

Ambulatory Blood Pressure Monitoring Daytime

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0332169
male or female
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
age 50-80 years (both inclusive) at screening
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients must be on stable doses with one or more antihypertensives
Descrição

Antihypertensive Agents Quantity Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
bmi <32 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute myocardial infarction in the last 6 months before screening
Descrição

Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
stroke in the last 6 months before screening
Descrição

Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
uncompensated heart failure (nyha class iv)
Descrição

Heart failure Uncompensated New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205433
UMLS CUI [1,3]
C1275491
angina pectoris with an anticipated need for administration of short-acting nitrates
Descrição

Angina Pectoris | Patient need for Nitrates Active short-term

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0028125
UMLS CUI [2,3]
C0205177
UMLS CUI [2,4]
C0443303
known, severe sleep apnoea
Descrição

Sleep Apnea Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0205082
abnormal laboratory values (i.e. > 2 x upper normal limit) at screening
Descrição

Laboratory test result abnormal | Raised laboratory findings

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0586721
subjects working night shifts (11 pm to 7 am)
Descrição

Night shift worker

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0555008
participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation.
Descrição

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
subjects with upper arm circumference ≤24 cm or ≥ 42 cm.
Descrição

Upper arm Circumference

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0446516
UMLS CUI [1,2]
C0332520
any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject's safety and/or may cause risk for poor protocol compliance
Descrição

Condition Study Subject Participation Status Inappropriate | Condition Interferes with Evaluation | Condition Affecting Patient safety | Condition At risk Poor compliance | Disease Serious | Mental disorders | Physical illness | Collaboration Attitude | Dementia | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0032646
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205404
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0683323
UMLS CUI [8,1]
C0282116
UMLS CUI [8,2]
C0004271
UMLS CUI [9]
C0497327
UMLS CUI [10]
C0038586
pregnant or lactating women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
Descrição

Childbearing Potential Contraceptive methods Unwilling | Gender Partner Contraceptive methods Unwilling | Exception Postmenopausal state | Exception Female Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0558080
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0232970
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015787
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Similar models

Eligibility Isolated Systolic Hypertension NCT01987284

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Pressure mean | Diastolic blood pressure mean
Item
mean systolic blood pressure ≥ 150 mmhg and mean diastolic blood pressure < 90 mmhg -
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Ambulatory Blood Pressure Monitoring Daytime
Item
as determined by daytime continuous ambulatory blood pressure measurement (abpm)
boolean
C0242876 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 50-80 years (both inclusive) at screening
boolean
C0001779 (UMLS CUI [1])
Antihypertensive Agents Quantity Dose Stable
Item
patients must be on stable doses with one or more antihypertensives
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Body mass index
Item
bmi <32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
acute myocardial infarction in the last 6 months before screening
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke in the last 6 months before screening
boolean
C0038454 (UMLS CUI [1])
Heart failure Uncompensated New York Heart Association Classification
Item
uncompensated heart failure (nyha class iv)
boolean
C0018801 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Angina Pectoris | Patient need for Nitrates Active short-term
Item
angina pectoris with an anticipated need for administration of short-acting nitrates
boolean
C0002962 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C0205177 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
Sleep Apnea Severe
Item
known, severe sleep apnoea
boolean
C0037315 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Laboratory test result abnormal | Raised laboratory findings
Item
abnormal laboratory values (i.e. > 2 x upper normal limit) at screening
boolean
C0438215 (UMLS CUI [1])
C0586721 (UMLS CUI [2])
Night shift worker
Item
subjects working night shifts (11 pm to 7 am)
boolean
C0555008 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Upper arm Circumference
Item
subjects with upper arm circumference ≤24 cm or ≥ 42 cm.
boolean
C0446516 (UMLS CUI [1,1])
C0332520 (UMLS CUI [1,2])
Condition Study Subject Participation Status Inappropriate | Condition Interferes with Evaluation | Condition Affecting Patient safety | Condition At risk Poor compliance | Disease Serious | Mental disorders | Physical illness | Collaboration Attitude | Dementia | Substance Use Disorders
Item
any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject's safety and/or may cause risk for poor protocol compliance
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0032646 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6])
C0683323 (UMLS CUI [7])
C0282116 (UMLS CUI [8,1])
C0004271 (UMLS CUI [8,2])
C0497327 (UMLS CUI [9])
C0038586 (UMLS CUI [10])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Gender Partner Contraceptive methods Unwilling | Exception Postmenopausal state | Exception Female Sterilization
Item
female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0015787 (UMLS CUI [4,2])
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