ID

28582

Description

Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00832572

Lien

https://clinicaltrials.gov/show/NCT00832572

Mots-clés

Versions (1)
  1. 23/01/2018 23/01/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

23 janvier 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00832572

Anglais

Eligibility Coronary Artery Disease NCT00832572

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females aged ≥ 18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
coronary artery disease with a clinically diagnosed peripheral neuropathy
Description

Coronary Artery Disease | Peripheral Neuropathy

Type de données

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0031117
willing and able to provide signed informed consent and health insurance portability and accountability act (hipaa) authorization
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of allergy or intolerance to ranolazine
Description

Hypersensitivity Ranolazine | Intolerance to Ranolazine

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073633
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0073633
any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see appendix e)
Description

Condition Excludes Ranolazine | Pharmaceutical Preparations Exclude Ranolazine

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0073633
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0073633
in the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
Description

Medical condition compromises Patient safety | Medical condition Interferes with Absorption Investigational New Drugs | Medical condition Interferes with Distribution Investigational New Drugs | Medical condition Interferes with Metabolism Investigational New Drugs | Medical condition Interferes with Excretion Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1378698
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0025519
UMLS CUI [4,4]
C0013230
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0221102
UMLS CUI [5,4]
C0013230
in the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
Description

ABNORMAL PHYSICAL FINDING | Exception Peripheral Neuropathy

Type de données

boolean

Alias
UMLS CUI [1]
C0149610
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0031117
use of any experimental or investigational drug or device within 30 days prior to screening
Description

Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in inclusion criterion 4)
Description

Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
had received prior treatment with, or investigational exposure to, ranolazine within 7 days prior to randomization
Description

Ranolazine Prior Therapy | Exposure to Ranolazine

Type de données

boolean

Alias
UMLS CUI [1,1]
C0073633
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0073633
clinically significant hepatic impairment
Description

Hepatic impairment

Type de données

boolean

Alias
UMLS CUI [1]
C0948807
had end-stage renal disease requiring dialysis
Description

End stage renal disease Requirement Dialysis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
psychological or addictive disorders (not limited to, but including drug and/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation
Description

Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorders Exclude Compliance behavior | Addictive Behavior Excludes Compliance behavior | Mental disorder Interferes with Interpretation Study data | Addictive Behavior Interferes with Interpretation Study data | Substance Dependence

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0085281
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1321605
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0681873
UMLS CUI [6,1]
C0085281
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0681873
UMLS CUI [7]
C0038580
positive pregnancy test at baseline (pre-randomization, day 0)
Description

Pregnancy test positive

Type de données

boolean

Alias
UMLS CUI [1]
C0240802
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Similar models

Eligibility Coronary Artery Disease NCT00832572

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease | Peripheral Neuropathy
Item
coronary artery disease with a clinically diagnosed peripheral neuropathy
boolean
C1956346 (UMLS CUI [1])
C0031117 (UMLS CUI [2])
Informed Consent
Item
willing and able to provide signed informed consent and health insurance portability and accountability act (hipaa) authorization
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Ranolazine | Intolerance to Ranolazine
Item
history of allergy or intolerance to ranolazine
boolean
C0020517 (UMLS CUI [1,1])
C0073633 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0073633 (UMLS CUI [2,2])
Condition Excludes Ranolazine | Pharmaceutical Preparations Exclude Ranolazine
Item
any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see appendix e)
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0073633 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0073633 (UMLS CUI [2,3])
Medical condition compromises Patient safety | Medical condition Interferes with Absorption Investigational New Drugs | Medical condition Interferes with Distribution Investigational New Drugs | Medical condition Interferes with Metabolism Investigational New Drugs | Medical condition Interferes with Excretion Investigational New Drugs
Item
in the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1378698 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0025519 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0221102 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
ABNORMAL PHYSICAL FINDING | Exception Peripheral Neuropathy
Item
in the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
boolean
C0149610 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0031117 (UMLS CUI [2,2])
Investigational New Drugs | Investigational Medical Device
Item
use of any experimental or investigational drug or device within 30 days prior to screening
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent
Item
pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in inclusion criterion 4)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Ranolazine Prior Therapy | Exposure to Ranolazine
Item
had received prior treatment with, or investigational exposure to, ranolazine within 7 days prior to randomization
boolean
C0073633 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0073633 (UMLS CUI [2,2])
Hepatic impairment
Item
clinically significant hepatic impairment
boolean
C0948807 (UMLS CUI [1])
End stage renal disease Requirement Dialysis
Item
had end-stage renal disease requiring dialysis
boolean
C0022661 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorders Exclude Compliance behavior | Addictive Behavior Excludes Compliance behavior | Mental disorder Interferes with Interpretation Study data | Addictive Behavior Interferes with Interpretation Study data | Substance Dependence
Item
psychological or addictive disorders (not limited to, but including drug and/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0085281 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0681873 (UMLS CUI [5,4])
C0085281 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0681873 (UMLS CUI [6,4])
C0038580 (UMLS CUI [7])
Pregnancy test positive
Item
positive pregnancy test at baseline (pre-randomization, day 0)
boolean
C0240802 (UMLS CUI [1])
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