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])
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])