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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valentis

Criteria

Inclusion Criteria:

• Diagnosis of peripheral arterial disease in both legs

• History of exercise limiting symptoms

Exclusion Criteria:

• Lower limb revascularization surgery with 2 months of study entry

• Diagnosis of critical limb ischemia