drugset

drugset / Trial / NCT00552188

Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event

NCT00552188 ↗

Phase 2 Completed 52 enrolled Tallikut Pharmaceuticals, Inc. Icahn School of Medicine at Mount Sinai · collab Massachusetts General Hospital · collab Montreal Heart Institute · collab University of Massachusetts, Worcester · collab Winthrop University Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.

Timeline

Start: 2007-10
Primary completion: 2009-10
Completion: 2009-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); VIA-2291 vs Placebo; p = 0.34; ANCOVA NCT00552188 ↗

Publications

Gaztanaga J, Farkouh M, Rudd JH, Brotz TM, Rosenbaum D, Mani V, Kerwin TC, Taub R, Tardif JC, Tawakol A, Fayad ZA. A phase 2 randomized, double-blind, placebo-controlled study of the effect of VIA-2291, a 5-lipoxygenase inhibitor, on vascular inflammation in patients after an acute coronary syndrome. Atherosclerosis. 2015 May;240(1):53-60. doi: 10.1016/j.atherosclerosis.2015.02.027. Epub 2015 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ATRELEUTON	Small molecule	100 mg	Oral

Indications