Trial of VLTS-589 in Subjects With Intermittent Claudication

Sponsor

Valentis (Industry)

Overall Status

Completed

CT.gov ID

NCT00068133

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Claudication Peripheral Vascular Disease	Genetic: Plasmid based Gene Transfer product-VLTS-589	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Pc	Birmingham	Alabama	United States	35211
2	Arizona Heart Institute	Phoenix	Arizona	United States	85016
3	Access Clinical Trials-Cardiovascular Research	Beverly Hills	California	United States	90210
4	Jacksonville Heart Center	Jacksonville	Florida	United States	32207
5	Heart Specialists of Sarasota Clinical Research Center	Sarasota	Florida	United States	34239
6	American Cardiovascular Research Institute	Atlanta	Georgia	United States	30342
7	Rush Presbyterian St. Luke's Medical Center	Chicago	Illinois	United States	60612
8	Prairie Heart Institution at St. John's Hospital	Springfield	Illinois	United States	62701
9	The Care Group	Indianapolis	Indiana	United States	46260
10	New Orleans Center for Clinical Research	New Orleans	Louisiana	United States	70119
11	Androscoggin Cardiology Associates	Auburn	Maine	United States	04210
12	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109
13	Minneapolis Heart Institution Foundation	Minneapolis	Minnesota	United States	55407
14	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
15	St. Vincent's Hospital	New York	New York	United States	10011
16	Duke Clinical Research Institute	Durham	North Carolina	United States	27715
17	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma	United States	73104
18	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
19	The Methodist Hospital	Houston	Texas	United States	77030
20	Daniel Gottleib, MD	Seattle	Washington	United States	98166

Sponsors and Collaborators

Valentis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00068133

Other Study ID Numbers:

VLTS-589-121

First Posted:

Sep 10, 2003

Last Update Posted:

Jun 24, 2005

Last Verified:

May 1, 2005

Additional relevant MeSH terms:

Vascular Diseases

Intermittent Claudication

Peripheral Vascular Diseases

Peripheral Arterial Disease

Study Results

No Results Posted as of Jun 24, 2005