ID

39439

Descripción

BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01345656

Link

https://clinicaltrials.gov/show/NCT01345656

Palabras clave

Versiones (1)
  1. 10/1/20 10/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01345656

Inglés

Eligibility Heart Failure NCT01345656

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
Descripción

Gender | Age | Postmenopausal state | Gender Childbearing Potential Absent | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C3831118
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0589114
UMLS CUI [7]
C0278321
UMLS CUI [8]
C0020699
clinical diagnosis of chf (chronic heart failure), either ischemic or non-ischemic, nyha (new york heart association) class ii - iii, treated with evidenced-based therapy for chf, e.g. beta-blockers and ace (angiotensin-converting enzyme) inhibitors or arb (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
Descripción

Chronic heart failure Ischemic New York Heart Association Classification | Chronic heart failure New York Heart Association Classification | Evidence based treatment Chronic heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Diuretics | Exception Medical contraindication | Exception Intolerance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C1740791
UMLS CUI [3,2]
C0264716
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0003015
UMLS CUI [6]
C0521942
UMLS CUI [7]
C0012798
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1301624
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C1744706
known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
Descripción

Kidney damage Duration | Structural renal abnormalities | Abnormal renal function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1408258
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C4012846
UMLS CUI [3]
C0151746
part a: 60 ml/min/1.73 m2 </= egfr (estimated glomerular filtration rate) < 90 ml/min/1.73 m2 (mdrd, modification of diet in renal disease) at the screening visit
Descripción

Part Upper case Roman letter | GFR estimation by MDRD

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0439103
UMLS CUI [2]
C2170215
part b: 30 ml/min/1.73 m2 </= egfr <= 60 ml/min/1.73 m2 (mdrd) at the screening visit
Descripción

Part Upper case Roman letter | GFR estimation by MDRD

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0439103
UMLS CUI [2]
C2170215
serum potassium </= 4.8 mmol/l at the screening visit
Descripción

Serum potassium measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0302353
systolic blood pressure >/= 90 mmhg without signs or symptoms of hypotension at the screening visit
Descripción

Systolic Pressure | Absence Sign or Symptom Hypotension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C3540840
UMLS CUI [2,3]
C0020649
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (part b only)
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Spironolactone allergy | Hypersensitivity Spironolactone Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
UMLS CUI [3]
C0571912
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0037982
UMLS CUI [4,3]
C0015237
subjects with anuria, acute renal failure, or addison's disease
Descripción

Anuria | Kidney Failure | Addison Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003460
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0001403
acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
Descripción

Acute Coronary Syndrome | Coronary Artery Disease Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0443343
valvular heart disease requiring surgical intervention during the course of the study
Descripción

Heart valve disease | Requirement Surgical intervention

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0549433
history of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
Descripción

Hospitalization Hyperkalemia | Hospitalization Kidney Failure | Etiology Aldosterone Antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0020461
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0035078
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0002007
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Similar models

Eligibility Heart Failure NCT01345656

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Postmenopausal state | Gender Childbearing Potential Absent | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy
Item
men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0015787 (UMLS CUI [5])
C0589114 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
C0020699 (UMLS CUI [8])
Chronic heart failure Ischemic New York Heart Association Classification | Chronic heart failure New York Heart Association Classification | Evidence based treatment Chronic heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Diuretics | Exception Medical contraindication | Exception Intolerance
Item
clinical diagnosis of chf (chronic heart failure), either ischemic or non-ischemic, nyha (new york heart association) class ii - iii, treated with evidenced-based therapy for chf, e.g. beta-blockers and ace (angiotensin-converting enzyme) inhibitors or arb (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
boolean
C0264716 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C1740791 (UMLS CUI [3,1])
C0264716 (UMLS CUI [3,2])
C0304516 (UMLS CUI [4])
C0003015 (UMLS CUI [5])
C0521942 (UMLS CUI [6])
C0012798 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1301624 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C1744706 (UMLS CUI [9,2])
Kidney damage Duration | Structural renal abnormalities | Abnormal renal function
Item
known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
boolean
C1408258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C4012846 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
Part Upper case Roman letter | GFR estimation by MDRD
Item
part a: 60 ml/min/1.73 m2 </= egfr (estimated glomerular filtration rate) < 90 ml/min/1.73 m2 (mdrd, modification of diet in renal disease) at the screening visit
boolean
C0449719 (UMLS CUI [1,1])
C0439103 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Part Upper case Roman letter | GFR estimation by MDRD
Item
part b: 30 ml/min/1.73 m2 </= egfr <= 60 ml/min/1.73 m2 (mdrd) at the screening visit
boolean
C0449719 (UMLS CUI [1,1])
C0439103 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Serum potassium measurement
Item
serum potassium </= 4.8 mmol/l at the screening visit
boolean
C0302353 (UMLS CUI [1])
Systolic Pressure | Absence Sign or Symptom Hypotension
Item
systolic blood pressure >/= 90 mmhg without signs or symptoms of hypotension at the screening visit
boolean
C0871470 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0020649 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Spironolactone allergy | Hypersensitivity Spironolactone Excipient
Item
known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (part b only)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0571912 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0037982 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Anuria | Kidney Failure | Addison Disease
Item
subjects with anuria, acute renal failure, or addison's disease
boolean
C0003460 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0001403 (UMLS CUI [3])
Acute Coronary Syndrome | Coronary Artery Disease Unstable
Item
acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
boolean
C0948089 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Heart valve disease | Requirement Surgical intervention
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0549433 (UMLS CUI [2,2])
Hospitalization Hyperkalemia | Hospitalization Kidney Failure | Etiology Aldosterone Antagonists
Item
history of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
boolean
C0019993 (UMLS CUI [1,1])
C0020461 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0035078 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0002007 (UMLS CUI [3,2])
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