CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
VIA-2291 +1 moredrug
Likely dose
VIA-2291 100 mg orally once daily for 12 weeksAI-extracted
Key inclusion· 6
  • ✓Carotid stenosis 60-90% with planned carotid endarterectomy
  • ✓Prior CVA or TIA >4 weeks before enrollment, or prior amaurosis fugax
  • ✓Diabetes with HbA1c 7-11% or two or more fasting glucose >6.9 mmol/L
  • ✓High-sensitivity C-reactive protein (hsCRP) >2 mg/L
Key exclusion· 10
  • ✕Acute CVA or TIA within 4 weeks of enrollment
  • ✕Ulcerated or unstable plaque requiring urgent endarterectomy
  • ✕Renal insufficiency with creatinine >1.5× upper limit of normal
  • ✕Cirrhosis, recent hepatitis, elevated ALT, or positive hepatitis B/C screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00352417
NCT00352417Phase 2Completed
CompareCT.gov

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Effects of VIA-2291, a 5-Lipoxygenase Inhibitor, on Atherosclerotic Plaque and Biomarkers of Vascular Inflammation in Patients With Carotid Stenosis Undergoing Elective Carotid Endarterectomy

Tallikut Pharmaceuticals, Inc.·interventional·Posted Jul 14, 2006·Updated Jul 27, 2012

In Brief

A Phase 2 clinical trial evaluating VIA-2291 and Placebo for Atherosclerosis. Completed, enrolled 50 participants across 3 sites.

Detailed Summary

This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2006
Enrollment StartJul 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.0 years ago

Interventions

VIA-2291drug

100 mg, oral dosing, 1 time daily for 12 weeks

Placebodrug

oral dosing, 1 time daily for 12 weeks