drugset / Trial / NCT00113009

Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

NCT00113009 ↗

Phase 2 Completed 148 enrolled Valentis
RandomizedSingle-groupDouble-blindTreatment

Summary

This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Timeline

Start
2005-03
Primary completion
—
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Vepoloxamer Small molecule 420 mg Intramuscular