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

This study has been terminated.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00832572
First received: January 28, 2009
Last updated: November 24, 2009
Last verified: November 2009

January 28, 2009
November 24, 2009
January 2009
April 2010   (final data collection date for primary outcome measure)
Reduction in neuropathic pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00832572 on ClinicalTrials.gov Archive Site
Quality of life questionnaire, other assessments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
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 will evaluate the effects of Ranexa (ranolazine) in patients with coronary artery disease who have painful peripheral neuropathy.

The study will include patients with coronary artery disease who have painful peripheral neuropathy and no condition that would exclude them from participation in the study. Eligibility requires neurological examination by the study doctor and assessment of the patient's pain. If eligible, patients will be randomized to receive blinded study medication for a total of 12 weeks.

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
    Ranexa twice a day for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg Ranexa twice a day for 3 weeks)
    Other Name: Ranolazine
  • Drug: placebo
    Placebo twice a day for 6 weeks
    Other Name: Placebo
  • Experimental: Ranexa
    Intervention: Drug: ranolazine
  • Placebo Comparator: Placebo
    Intervention: 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
50
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must have coronary artery disease and pain consistent with peripheral neuropathy

Exclusion Criteria:

  • Pregnant or breast-feeding, or (if pre-menopausal), not practicing an acceptable method of birth control
  • Any condition that could preclude the safe use of Ranexa
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832572
CVT 3042
No
Philip Sager, Vice President, Clinical Research, Gilead Sciences
Gilead Sciences
Not Provided
Principal Investigator: Craig Walker, MD Cardiovascular Institute of the South Clinical Research Corporation
Gilead Sciences
November 2009

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