ID

28379

Descripción

Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT00709865

Link

https://clinicaltrials.gov/show/NCT00709865

Palabras clave

Versiones (1)
  1. 9/1/18 9/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00709865

Inglés

Eligibility Congestive Heart Failure NCT00709865

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous diagnosis of heart failure.
Descripción

Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
must have adhf, requiring hospitalization, with clinical evidence for volume overload
Descripción

ADHF | Hospitalization Required | Volume overload

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1609524
UMLS CUI [2]
C1708385
UMLS CUI [3]
C0546817
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of an allergic reaction to any xanthine-containing substance.
Descripción

Xanthine allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571073
history of seizure
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
history of stroke
Descripción

Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
myocardial infarction
Descripción

Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
uncorrected hemodynamically significant primary valvular disease or known obstructive or restrictive cardiomyopathy.
Descripción

Primary valvular heart disease Hemodynamic Significant uncorrected | Obstructive Cardiomyopathy | Restrictive cardiomyopathy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2064629
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C4072785
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
serious systemic infection
Descripción

Sepsis Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205404
major surgical procedures within 30 days
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
acute coronary syndrome
Descripción

Acute Coronary Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
cardiogenic shock
Descripción

Shock, Cardiogenic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036980
baseline body weight >150 kg
Descripción

Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
participation in any other investigational study of drugs or devices within 30 days prior to screening
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
nursing mothers, pregnant women, or women planning on becoming pregnant during the study
Descripción

Breast Feeding | Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
presence of any clinically significant condition that might interfere with optimal safe participation in this study
Descripción

Medical condition Interferes with Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
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Similar models

Eligibility Congestive Heart Failure NCT00709865

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
previous diagnosis of heart failure.
boolean
C0018801 (UMLS CUI [1])
ADHF | Hospitalization Required | Volume overload
Item
must have adhf, requiring hospitalization, with clinical evidence for volume overload
boolean
C1609524 (UMLS CUI [1])
C1708385 (UMLS CUI [2])
C0546817 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Xanthine allergy
Item
history of an allergic reaction to any xanthine-containing substance.
boolean
C0571073 (UMLS CUI [1])
Epilepsy
Item
history of seizure
boolean
C0014544 (UMLS CUI [1])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Primary valvular heart disease Hemodynamic Significant uncorrected | Obstructive Cardiomyopathy | Restrictive cardiomyopathy
Item
uncorrected hemodynamically significant primary valvular disease or known obstructive or restrictive cardiomyopathy.
boolean
C2064629 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C4072785 (UMLS CUI [1,4])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
Sepsis Serious
Item
serious systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Major surgery
Item
major surgical procedures within 30 days
boolean
C0679637 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Body Weight
Item
baseline body weight >150 kg
boolean
C0005910 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in any other investigational study of drugs or devices within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
nursing mothers, pregnant women, or women planning on becoming pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Medical condition Interferes with Study Subject Participation Status
Item
presence of any clinically significant condition that might interfere with optimal safe participation in this study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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