Phase
Condition
Coronary Artery Disease
Myocardial Ischemia
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females aged ≥ 18 years
Coronary artery disease with a clinically diagnosed peripheral neuropathy
Willing and able to provide signed informed consent and Health Insurance Portabilityand Accountability Act (HIPAA) authorization
Willing and able to comply with the requirements of the protocol and follow directionsfrom the clinic staff
Exclusion
Exclusion Criteria:
History of allergy or intolerance to ranolazine
Any condition or concomitant medication that would have precluded the safe use ofranolazine as outlined in the prescribing information sheet (see Appendix E)
In the judgment of the investigator, any clinically-significant ongoing medicalcondition that might jeopardize the patient's safety or interfere with the absorption,distribution, metabolism or excretion of the study drug
In the judgment of the investigator, clinically-significant abnormal physical findingsduring screening (excluding the patient's peripheral neuropathy condition)
Use of any experimental or investigational drug or device within 30 days prior toscreening
Pregnant or breast feeding, or (if premenopausal), not practicing an acceptable methodof birth control (as detailed in Inclusion Criterion 4)
Had received prior treatment with, or investigational exposure to, ranolazine within 7days prior to randomization
Clinically significant hepatic impairment
Had end-stage renal disease requiring dialysis
Psychological or addictive disorders (not limited to, but including drug and/oralcohol dependency) that may have precluded patient consent or compliance, or that mayhave confounded study interpretation
Positive pregnancy test at Baseline (pre-randomization, Day 0)
Study Design
Connect with a study center
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana 70360
United StatesSite Not Available
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