Status:
TERMINATED
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
Lead Sponsor:
Gilead Sciences
Conditions:
Coronary Artery Disease
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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 Portability and Accountability Act (HIPAA) authorization
- Willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
Exclusion
- History of allergy or intolerance to ranolazine
- Any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see Appendix E)
- 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
- In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
- Use of any experimental or investigational drug or device within 30 days prior to screening
- Pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in Inclusion Criterion 4)
- Had received prior treatment with, or investigational exposure to, ranolazine within 7 days 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/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation
- Positive pregnancy test at Baseline (pre-randomization, Day 0)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00832572
Start Date
January 1 2009
End Date
June 1 2009
Last Update
June 30 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana, United States, 70360