Trial of VLTS-589 in Subjects With Intermittent Claudication

NCT ID: NCT00068133

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intermittent Claudication Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Plasmid based Gene Transfer product-VLTS-589

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valentis

INDUSTRY

Sponsor Role lead

Locations

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Cardiology Pc

Birmingham, Alabama, United States

Site Status

Arizona Heart Institute

Phoenix, Arizona, United States

Site Status

Access Clinical Trials-Cardiovascular Research

Beverly Hills, California, United States

Site Status

Jacksonville Heart Center

Jacksonville, Florida, United States

Site Status

Heart Specialists of Sarasota Clinical Research Center

Sarasota, Florida, United States

Site Status

American Cardiovascular Research Institute

Atlanta, Georgia, United States

Site Status

Rush Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

Prairie Heart Institution at St. John's Hospital

Springfield, Illinois, United States

Site Status

The Care Group

Indianapolis, Indiana, United States

Site Status

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Site Status

Androscoggin Cardiology Associates

Auburn, Maine, United States

Site Status

University of Michigan Health Systems

Ann Arbor, Michigan, United States

Site Status

Minneapolis Heart Institution Foundation

Minneapolis, Minnesota, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

St. Vincent's Hospital

New York, New York, United States

Site Status

Duke Clinical Research Institute

Durham, North Carolina, United States

Site Status

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Daniel Gottleib, MD

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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VLTS-589-121

Identifier Type: -

Identifier Source: org_study_id