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Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00352417
First received: July 12, 2006
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
Results First Received: June 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Atherosclerosis
Interventions: Drug: VIA-2291
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from three Italian Medical Centers

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
VIA-2291 100-mg dose
Matching Placebo Placebo Dose

Participant Flow:   Overall Study
    VIA-2291     Matching Placebo  
STARTED     24     26  
COMPLETED     19     21  
NOT COMPLETED     5     5  
Adverse Event                 1                 0  
Protocol Violation                 0                 2  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 1                 0  
Schedule Change                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
VIA-2291 100-mg dose
Matching Placebo Placebo Dose
Total Total of all reporting groups

Baseline Measures
    VIA-2291     Matching Placebo     Total  
Number of Participants  
[units: participants]
 		  24     26     50  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     8     19  
>=65 years     13     18     31  
Age  
[units: years]
Mean ± Standard Deviation 		  66.8  ± 8.86     69.5  ± 8.73     68.2  ± 8.81  
Gender  
[units: participants]
 		     
Female     11     14     25  
Male     13     12     25  
Region of Enrollment  
[units: participants]
 		     
Italy     24     26     50  



  Outcome Measures
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1.  Primary:   Percent Cross-sectional Area of Macrophages in Plaque Tissue   [ Time Frame: 12 weeks ]
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2.  Secondary:   Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue   [ Time Frame: 12 weeks ]
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3.  Secondary:   Change From Baseline in Whole Blood Leukotriene B4 Production   [ Time Frame: Baseline and 12 weeks ]
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4.  Secondary:   Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine   [ Time Frame: Baseline and 12 Weeks ]
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5.  Secondary:   Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)   [ Time Frame: Baseline and 12 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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 small number, less than optimal quality, and diversity of types of plaque samples posed a significant limitation to the interpretation of the plaque data in this study.  


Results Point of Contact:  
Name/Title: Brian Cunningham, MD
Organization: Tallikut Pharmaceuticals, Inc.
phone: 312-505-0420
e-mail: brian@baycitycapital.com


No publications provided


Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00352417     History of Changes
Other Study ID Numbers: VIA-2291-02, 2006-001635-21
Study First Received: July 12, 2006
Results First Received: June 15, 2012
Last Updated: July 19, 2012
Health Authority: Italy: Ethics Committee