Trial of VLTS-589 in Subjects With Intermittent Claudication

June 23, 2005 updated by: Valentis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology PC
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Heart Institute
    • California
      • Beverly Hills, California, United States, 90210
        • Access Clinical Trials-Cardiovascular Research
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Jacksonville Heart Center
      • Sarasota, Florida, United States, 34239
        • Heart Specialists of Sarasota Clinical Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • American Cardiovascular Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian St. Luke's Medical Center
      • Springfield, Illinois, United States, 62701
        • Prairie Heart Institution at St. John's Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Care Group
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • New Orleans Center for Clinical Research
    • Maine
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiology Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institution Foundation
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10011
        • St. Vincent's Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27715
        • Duke Clinical Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Washington
      • Seattle, Washington, United States, 98166
        • Daniel Gottleib, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valentis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 8, 2003

First Submitted That Met QC Criteria

September 9, 2003

First Posted (Estimate)

September 10, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLTS-589-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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