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
Results First Received: May 28, 2013  
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
Conditions: Coronary Artery Disease
Pain
Peripheral Nervous System Diseases
Polyneuropathy
Interventions: Drug: Ranolazine
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Five participants were enrolled and treated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo/Ranolazine Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
Ranolazine/Placebo Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).

Participant Flow for 2 periods

Period 1:   Period 1
    Placebo/Ranolazine     Ranolazine/Placebo  
STARTED     3     2  
COMPLETED     3     2  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Placebo/Ranolazine     Ranolazine/Placebo  
STARTED     3     2  
COMPLETED     3     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled and treated participants

Reporting Groups
  Description
Placebo/Ranolazine Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
Ranolazine/Placebo Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
Total Total of all reporting groups

Baseline Measures
    Placebo/Ranolazine     Ranolazine/Placebo     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     2     2  
>=65 years     3     0     3  
Gender  
[units: participants]
     
Female     1     1     2  
Male     2     1     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction in Neuropathic Pain   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire   [ Time Frame: Baseline to Week 6 ]

3.  Secondary:   Response to Thermal and Mechanical Stimuli   [ Time Frame: Baseline to Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped after 5 participants were enrolled. No outcome measure analyses were performed. Adverse events were collected and reported to the study center's Institutional Review Board.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00832572     History of Changes
Other Study ID Numbers: CVT 3042
Study First Received: January 28, 2009
Results First Received: May 28, 2013
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board