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

Completed · Phase 2

Conditions studied: Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00113009

Run by

Valentis

People needed

148

Starts

2005-03-01

Expected to finish

2006-07-01

Last updated by the study team

2007-11-22

Who can join

Age: 40 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of peripheral arterial disease in both legs
• History of exercise limiting symptoms

You may not qualify if…

• Lower limb revascularization surgery with 2 months of study entry
• Diagnosis of critical limb ischemia

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Beverly Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mountain View, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Houma, Louisiana, United States
• Study site — Thibodaux, Louisiana, United States
• Study site — Auburn, Maine, United States
• Study site — Baltimore, Maryland, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Study site — Flint, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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