Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Mount Sinai School of Medicine
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00552188
First received: October 31, 2007
Last updated: June 6, 2013
Last verified: June 2013
Results First Received: June 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: VIA-2291
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
Patients were screened between November 2007 and April 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had Acute Coronory Syndrome (ACS) 1-3 months prior to randomization and must have received concomitant statin therapy for a minimum of 4 weeks and had a stable statin dose regimen for 2 weeks prior to randomization.

Reporting Groups
  Description
VIA-2291 VIA-2291 100mg
Placebo Matching placebo

Participant Flow:   Overall Study
    VIA-2291     Placebo  
STARTED     26     26  
COMPLETED     24     21  
NOT COMPLETED     2     5  
Adverse Event                 0                 2  
Lost to Follow-up                 2                 1  
Withdrawal of consent                 0                 1  
Subject returned to home country                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
VIA-2291 VIA-2291 100mg
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
    VIA-2291     Placebo     Total  
Number of Participants  
[units: participants]
  26     26     52  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     19     40  
>=65 years     5     7     12  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 9.50     58.7  ± 8.00     57.4  ± 8.79  
Gender  
[units: participants]
     
Female     2     4     6  
Male     24     22     46  
Region of Enrollment  
[units: participants]
     
United States     15     16     31  
Canada     11     10     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Plaque Imaging After 24 Weeks   [ Time Frame: Baseline and 24 Weeks ]

2.  Secondary:   Change From Baseline in Plaque Imaging After 6 Weeks   [ Time Frame: Baseline and 6 Weeks ]


  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
No text entered.


  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: 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: NCT00552188     History of Changes
Other Study ID Numbers: VIA-2291-03
Study First Received: October 31, 2007
Results First Received: June 6, 2013
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration