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Study Effect of VIA-2291 on Vascular Inflammation

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ClinicalTrials.gov Identifier: NCT00358826
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : July 23, 2012
Last Update Posted : July 23, 2012
Sponsor:
Collaborator:
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 28, 2006
First Posted Date  ICMJE August 1, 2006
Results First Submitted Date  ICMJE June 15, 2012
Results First Posted Date  ICMJE July 23, 2012
Last Update Posted Date July 23, 2012
Study Start Date  ICMJE July 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood [ Time Frame: Baseline and 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
Changes in biomarkers of vascular inflammation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Change From Baseline in Leukotriene E4 (LTE4) [ Time Frame: Baseline and 12 weeks ]
    Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
  • Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study [ Time Frame: Baseline and 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2012)
  • Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy [ Time Frame: Baseline and 24 weeks ]
  • Change From Baseline in Noncalcified Plaque Volume [ Time Frame: Baseline and 24 weeks ]
  • Change From Baseline in Mean Plaque Density [ Time Frame: Baseline and 24 weeks ]
    Plaque density is expressed in Hounsfield Units (HU)
  • Change From Baseline in Percent Stenosis [ Time Frame: Baseline and 24 weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Effect of VIA-2291 on Vascular Inflammation
Official Title  ICMJE Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event
Brief Summary This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events
Detailed Description This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: VIA-2291
    oral dosing, 1 time daily for 12 or 24 weeks
    Other Name: atreleuton
  • Drug: Placebo
    oral dosing, 1 time daily for 12 or 24 weeks
Study Arms  ICMJE
  • Experimental: VIA-2291 25 mg
    VIA-2291 25 mg
    Intervention: Drug: VIA-2291
  • Experimental: VIA-2291 50 mg
    VIA-2291 50 mg
    Intervention: Drug: VIA-2291
  • Experimental: VIA-2291 100 mg
    VIA-2291 100 mg
    Intervention: Drug: VIA-2291
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2009)
191
Original Enrollment  ICMJE
 (submitted: July 28, 2006)
200
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients are to be of non-childbearing potential
  • Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
  • Patient has documented coronary artery disease

Exclusion Criteria:

  • Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
  • Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
  • Uncontrolled diabetes mellitus within 1 month prior to study screening
  • Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
  • Previous coronary artery bypass graft (CABG) surgery
  • Planned additional cardiac intervention
  • Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
  • Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
  • Acetaminophen use in any form in the 7 days before enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00358826
Other Study ID Numbers  ICMJE VIA-2291-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tallikut Pharmaceuticals, Inc.
Study Sponsor  ICMJE Tallikut Pharmaceuticals, Inc.
Collaborators  ICMJE Montreal Heart Institute
Investigators  ICMJE
Study Director: Rebecca Taub, MD VIA Pharmaceuticals
PRS Account Tallikut Pharmaceuticals, Inc.
Verification Date July 2012

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