NCT00068133

Trial of VLTS-589 in Subjects With Intermittent Claudication

A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Valentis · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.

Conditions

• Intermittent Claudication
• Peripheral Vascular Disease

Interventions

Type	Name	Description
GENETIC	Plasmid based Gene Transfer product-VLTS-589

Timeline

• Start date: 2003-06-01
• Completion: 2005-06-01
• First posted: 2003-09-10
• Last updated: 2005-06-24

Locations

20 sites across 1 country: United States