Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy

Last updated: May 23, 2014
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

4

Condition

Coronary Artery Disease

Myocardial Ischemia

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00832572
CVT 3042
  • Ages > 18
  • All Genders

Study Summary

This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.

Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.

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

Total Participants: 5
Study Start date:
January 01, 2009
Estimated Completion Date:
June 30, 2009

Connect with a study center

  • Cardiovascular Institute of the South Clinical Research Corporation

    Houma, Louisiana 70360
    United States

    Site Not Available

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