ID

39917

Descrição

Nebivolol in the Supine Hypertension of Autonomic Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01044693

Link

https://clinicaltrials.gov/show/NCT01044693

Palavras-chave

Versões (1)
  1. 04/03/2020 04/03/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de março de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT01044693

Inglês

Eligibility Hypertension NCT01044693

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female and aged 18 years or over.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of orthostatic hypotension associated with primary autonomic failure (parkinson disease, multiple system atrophy and pure autonomic failure).
Descrição

Hypotension, Orthostatic | Autonomic Failure Primary | Parkinson Disease | Multiple System Atrophy | Pure Autonomic Failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2,1]
C0393911
UMLS CUI [2,2]
C0205225
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0393571
UMLS CUI [5]
C0393911
a documented fall in systolic blood pressure of at least 20 mmhg, or in diastolic blood pressure of at least 10 mmhg, within 3 minutes after standing.
Descrição

Systolic Pressure Decrease Amount | Diastolic blood pressure Decrease Amount | Status post Standing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0547047
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0547047
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0231472
supine hypertension, defined as a systolic blood pressure >150 mm hg or diastolic blood pressure > 90 mm hg.
Descrição

Supine hypertension | Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4076686
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
Descrição

Prescribed medication Dose Changed | Prescribed medication Frequency Changed | Prescribed medication Type Changed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239117
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C2239117
UMLS CUI [2,2]
C0439603
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C2239117
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C0392747
women of childbearing potential who are not using a medically accepted contraception.
Descrição

Childbearing Potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
Descrição

Heart Disease | Systemic disease | Liver disease | Kidney Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0442893
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
diabetes mellitus or insipidus.
Descrição

Diabetes Mellitus | Diabetes Insipidus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0011848
in the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
Descrição

Abnormality Clinical examination | Laboratory test result abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C1456356
UMLS CUI [2]
C0438215
in the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
Descrição

Poor compliance Due to Social situation | Poor compliance Due to Family problem

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0748872
UMLS CUI [2,1]
C0032646
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0424960
in the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
Descrição

Mental disorder Interferes with Diagnosis | Mental disorder Interferes with Completion of clinical trial | Schizophrenia | Major Depressive Disorder | Dementia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0011900
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3]
C0036341
UMLS CUI [4]
C1269683
UMLS CUI [5]
C0497327
are not able or willing to comply with the study requirements for the duration of the study.
Descrição

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
Descrição

Adrenergic beta-1 Receptor Antagonists | Amiodarone | Nitrates | Adrenergic alpha-Antagonists | tamsulosin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2]
C0002598
UMLS CUI [3]
C0028125
UMLS CUI [4]
C0001641
UMLS CUI [5]
C0257343
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Similar models

Eligibility Hypertension NCT01044693

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female and aged 18 years or over.
boolean
C0001779 (UMLS CUI [1])
Hypotension, Orthostatic | Autonomic Failure Primary | Parkinson Disease | Multiple System Atrophy | Pure Autonomic Failure
Item
clinical diagnosis of orthostatic hypotension associated with primary autonomic failure (parkinson disease, multiple system atrophy and pure autonomic failure).
boolean
C0020651 (UMLS CUI [1])
C0393911 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0030567 (UMLS CUI [3])
C0393571 (UMLS CUI [4])
C0393911 (UMLS CUI [5])
Systolic Pressure Decrease Amount | Diastolic blood pressure Decrease Amount | Status post Standing
Item
a documented fall in systolic blood pressure of at least 20 mmhg, or in diastolic blood pressure of at least 10 mmhg, within 3 minutes after standing.
boolean
C0871470 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0428883 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0231472 (UMLS CUI [3,2])
Supine hypertension | Systolic Pressure | Diastolic blood pressure
Item
supine hypertension, defined as a systolic blood pressure >150 mm hg or diastolic blood pressure > 90 mm hg.
boolean
C4076686 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Informed Consent
Item
provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prescribed medication Dose Changed | Prescribed medication Frequency Changed | Prescribed medication Type Changed
Item
have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
boolean
C2239117 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C2239117 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C2239117 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential who are not using a medically accepted contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Heart Disease | Systemic disease | Liver disease | Kidney Disease
Item
have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
boolean
C0018799 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Diabetes Mellitus | Diabetes Insipidus
Item
diabetes mellitus or insipidus.
boolean
C0011849 (UMLS CUI [1])
C0011848 (UMLS CUI [2])
Abnormality Clinical examination | Laboratory test result abnormal
Item
in the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
boolean
C1704258 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Poor compliance Due to Social situation | Poor compliance Due to Family problem
Item
in the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
boolean
C0032646 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0748872 (UMLS CUI [1,3])
C0032646 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0424960 (UMLS CUI [2,3])
Mental disorder Interferes with Diagnosis | Mental disorder Interferes with Completion of clinical trial | Schizophrenia | Major Depressive Disorder | Dementia
Item
in the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0036341 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
C0497327 (UMLS CUI [5])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
are not able or willing to comply with the study requirements for the duration of the study.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Adrenergic beta-1 Receptor Antagonists | Amiodarone | Nitrates | Adrenergic alpha-Antagonists | tamsulosin
Item
persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
boolean
C0304516 (UMLS CUI [1])
C0002598 (UMLS CUI [2])
C0028125 (UMLS CUI [3])
C0001641 (UMLS CUI [4])
C0257343 (UMLS CUI [5])
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