Study Effect of VIA-2291 on Vascular Inflammation

July 19, 2012 updated by: Tallikut Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

191

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II HSC
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H2L 4M1
        • Notre Dame Hospital
      • Montreal, Quebec, Canada, H4J 1C5
        • Hospital Sacre-Coeur
      • Saint-Charles-Borromee, Quebec, Canada, J6E 6J2
        • Constituante Centre Hospitalier Regional De Lanaudiere
  • United States
    • Florida
      • Melbourne, Florida, United States, 32901
        • MIMA Century Research Associates
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates Research, LLC
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research Foundation
    • Texas
      • Victoria, Texas, United States, 77901
        • Victoria Heart and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral dosing, 1 time daily for 12 or 24 weeks
Experimental: VIA-2291 25 mg
Drug: VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Other Names:
  • atreleuton
Experimental: VIA-2291 50 mg
Drug: VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Other Names:
  • atreleuton
Experimental: VIA-2291 100 mg
Drug: VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Other Names:
  • atreleuton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 weeks
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
Change From Baseline in Noncalcified Plaque Volume
Time Frame: Baseline and 24 weeks
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)
Baseline and 24 weeks
Change From Baseline in Percent Stenosis
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tallikut Pharmaceuticals, Inc.

Collaborators

Montreal Heart Institute

Investigators

  • Study Director: Rebecca Taub, MD, VIA Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIA-2291-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on VIA-2291

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe