Trial of VLTS-589 in Subjects With Intermittent Claudication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068133
Recruitment Status : Completed
First Posted : September 10, 2003
Last Update Posted : June 24, 2005
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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 Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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 : June 2003
Study Completion Date : June 2005

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00068133

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Valentis Identifier: NCT00068133     History of Changes
Other Study ID Numbers: VLTS-589-121
First Posted: September 10, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2005

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Peripheral Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Signs and Symptoms