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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
History of Changes
  Purpose

This study will evaluate the effects of Ranexa (ranolazine) in patients with coronary artery disease who have painful peripheral neuropathy.


Condition Intervention Phase
Coronary Artery Disease
Pain
Peripheral Nervous System Diseases
Polyneuropathy
 Drug: ranolazine
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy

Resource links provided by NLM:

Drug Information available for: Ranolazine
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Reduction in neuropathic pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life questionnaire, other assessments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranexa 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
Placebo Comparator: Placebo Drug: placebo
Placebo twice a day for 6 weeks
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832572

Locations
United States, Louisiana
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana, United States, 70360
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Craig Walker, MD Cardiovascular Institute of the South Clinical Research Corporation
  More Information

Additional Information:
The Neuropathy Association, a public, non-profit organization providing information and support for patients with neuropathy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00832572     History of Changes
Other Study ID Numbers: CVT 3042
Study First Received: January 28, 2009
Last Updated: November 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Gilead Sciences:
Coronary Artery Disease
Pain
Peripheral Neuropathy
Polyneuropathy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Nervous System Diseases
Peripheral Nervous System Diseases
Polyneuropathies
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neuromuscular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013