Trial of VLTS-589 in Subjects With Intermittent Claudication

Completed · Phase 2

Conditions studied: Intermittent Claudication, Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00068133

Run by

Valentis

People needed

100

Starts

2003-06-01

Expected to finish

2005-06-01

Last updated by the study team

2005-06-24

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women between 40 and 80 years of age,
• Must give informed consent,
• Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness

You may not qualify if…

• Ulcers or gangrene,
• History of cancer (except skin cancer) within the past 5 years,
• Participation in another clinical trial within 30 days of enrollment in this trial,
• Unwillingness or inability to comply with all study requirements

Where it is running

• Cardiology Pc — Birmingham, Alabama, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• Access Clinical Trials-Cardiovascular Research — Beverly Hills, California, United States
• Jacksonville Heart Center — Jacksonville, Florida, United States
• Heart Specialists of Sarasota Clinical Research Center — Sarasota, Florida, United States
• American Cardiovascular Research Institute — Atlanta, Georgia, United States
• Rush Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Prairie Heart Institution at St. John's Hospital — Springfield, Illinois, United States
• The Care Group — Indianapolis, Indiana, United States
• New Orleans Center for Clinical Research — New Orleans, Louisiana, United States
• Androscoggin Cardiology Associates — Auburn, Maine, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Minneapolis Heart Institution Foundation — Minneapolis, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• St. Vincent's Hospital — New York, New York, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States
• University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The Methodist Hospital — Houston, Texas, United States
• Daniel Gottleib, MD — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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