Study Effect of VIA-2291 on Vascular Inflammation

Tallikut Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: Placebo; Drug: VIA-2291

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00358826

VIA-2291-01

Details and patient eligibility

About

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

Full description

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Enrollment: 191 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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191 participants in 4 patient groups, including a placebo group

VIA-2291 25 mg

Experimental group

Description:

VIA-2291 25 mg

Treatment:

Drug: VIA-2291

VIA-2291 50 mg

Experimental group

Description:

VIA-2291 50 mg

Treatment:

Drug: VIA-2291

VIA-2291 100 mg

Experimental group

Description:

VIA-2291 100 mg

Treatment:

Drug: VIA-2291

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo