Status:
COMPLETED
Study Effect of VIA-2291 on Vascular Inflammation
Lead Sponsor:
Tallikut Pharmaceuticals, Inc.
Collaborating Sponsors:
Montreal Heart Institute
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00358826
Start Date
July 1 2006
End Date
September 1 2008
Last Update
July 23 2012
Active Locations (12)
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1
MIMA Century Research Associates
Melbourne, Florida, United States, 32901
2
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
3
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
4
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States, 27401