Study Effect of VIA-2291 on Vascular Inflammation

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: VIA-2291; Drug: Placebo

• Registration Number: NCT00358826
• Lead Sponsor: Tallikut Pharmaceuticals, Inc.

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study First Posted: 2006-08-01
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Results First Submitted: 2012-06-15
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-19
• Last Update Submitted: 2012-07-19
• Results First Posted: 2012-07-23
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIA-2291 25 mg	VIA-2291	VIA-2291 25 mg
VIA-2291 50 mg	VIA-2291	VIA-2291 50 mg
Placebo	Placebo	Placebo
VIA-2291 100 mg	VIA-2291	VIA-2291 100 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Leukotriene E4 (LTE4)	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	Baseline and 12 weeks

Trial Locations

Locations (12)

MIMA Century Research Associates; 🇺🇸 Melbourne, Florida, United States

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

Cardiology Associates Research, LLC; 🇺🇸 Tupelo, Mississippi, United States

LeBauer Cardiovascular Research Foundation; 🇺🇸 Greensboro, North Carolina, United States

Victoria Heart and Vascular Center; 🇺🇸 Victoria, Texas, United States

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Victoria Heart Institute Foundation; 🇨🇦 Victoria, British Columbia, Canada

Queen Elizabeth II HSC; 🇨🇦 Halifax, Nova Scotia, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Notre Dame Hospital; 🇨🇦 Montreal, Quebec, Canada

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