Trial of VLTS-589 in Subjects With Intermittent Claudication

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068133
• Other study ID #: VLTS-589-121
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2003
• Last updated: June 23, 2005
• Start date: June 2003
• Est. completion date: June 2005

Study information

• Verified date: May 2005
• Source: Valentis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Genetic:
• Plasmid based Gene Transfer product-VLTS-589

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Valentis

Country where clinical trial is conducted

United States,