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

NCT ID: NCT00832572

Last Updated: 2014-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

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

Conditions

Coronary Artery Disease; Pain; Peripheral Nervous System Diseases; Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo-Ranolazine

Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks).

Placebo

Intervention Type: DRUG

Placebo to match ranolazine administered twice a day for 6 weeks

Ranolazine-Placebo

Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks).

Placebo

Intervention Type: DRUG

Placebo to match ranolazine administered twice a day for 6 weeks

Interventions

Ranolazine

Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks).

Intervention Type: DRUG

Placebo

Placebo to match ranolazine administered twice a day for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Ranexa

Eligibility Criteria

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 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute of the South Clinical Research Corporation

Locations

Cardiovascular Institute of the South Clinical Research Corporation

Houma, Louisiana, United States

Countries

United States

Related Links

http://www.neuropathy.org/

The Neuropathy Association, a public, non-profit organization providing information and support for patients with neuropathy

Other Identifiers

CVT 3042

Identifier Type: -

Identifier Source: org_study_id