NCT00113009

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

A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (planned)
• Sponsor: Valentis · Industry
• Sex: All
• Age: 40 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with 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.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DRUG	VLTS-934

Timeline

• Start date: 2005-03-01
• Completion: 2006-07-01
• First posted: 2005-06-03
• Last updated: 2007-11-22

Locations

32 sites across 1 country: United States