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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00832572
First received: January 28, 2009
Last updated: May 23, 2014
Last verified: May 2014

January 28, 2009
May 23, 2014
January 2009
June 2009   (final data collection date for primary outcome measure)
Reduction in Neuropathic Pain [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
Reduction in neuropathic pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00832572 on ClinicalTrials.gov Archive Site
  • Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    The participant quality of life assessed utilizing the SF-36v2 questionnaire
  • Response to Thermal and Mechanical Stimuli [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests
Quality of life questionnaire, other assessments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Pain
  • Peripheral Nervous System Diseases
  • Polyneuropathy
  • Drug: 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).
    Other Name: Ranexa
  • Drug: Placebo
    Placebo to match ranolazine administered twice a day for 6 weeks
  • Experimental: Placebo-Ranolazine
    Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.
    Interventions:
    • Drug: Ranolazine
    • Drug: Placebo
  • Experimental: Ranolazine-Placebo
    Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.
    Interventions:
    • Drug: Ranolazine
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
June 2009
June 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832572
CVT 3042
No
Gilead Sciences
Gilead Sciences
Not Provided
Principal Investigator: Craig Walker, MD Cardiovascular Institute of the South Clinical Research Corporation
Gilead Sciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP