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Trial of VLTS-589 in Subjects With Intermittent Claudication

Primary Purpose

Intermittent Claudication, Peripheral Vascular Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plasmid based Gene Transfer product-VLTS-589
Sponsored by
Valentis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiology Pc
  • Arizona Heart Institute
  • Access Clinical Trials-Cardiovascular Research
  • Jacksonville Heart Center
  • Heart Specialists of Sarasota Clinical Research Center
  • American Cardiovascular Research Institute
  • Rush Presbyterian St. Luke's Medical Center
  • Prairie Heart Institution at St. John's Hospital
  • The Care Group
  • New Orleans Center for Clinical Research
  • Androscoggin Cardiology Associates
  • University of Michigan Health Systems
  • Minneapolis Heart Institution Foundation
  • Dartmouth-Hitchcock Medical Center
  • St. Vincent's Hospital
  • Duke Clinical Research Institute
  • University of Oklahoma Health Science Center
  • Vanderbilt University Medical Center
  • The Methodist Hospital
  • Daniel Gottleib, MD

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2003
Last Updated
June 23, 2005
Sponsor
Valentis
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1. Study Identification

Unique Protocol Identification Number
NCT00068133
Brief Title
Trial of VLTS-589 in Subjects With Intermittent Claudication
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 Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Valentis

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Peripheral Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
Plasmid based Gene Transfer product-VLTS-589

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cardiology Pc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Access Clinical Trials-Cardiovascular Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Jacksonville Heart Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Heart Specialists of Sarasota Clinical Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
American Cardiovascular Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Prairie Heart Institution at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
The Care Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minneapolis Heart Institution Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
St. Vincent's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27715
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Daniel Gottleib, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States

12. IPD Sharing Statement

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Trial of VLTS-589 in Subjects With Intermittent Claudication

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