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Trial of VLTS-589 in Subjects With Intermittent Claudication

This study has been completed.
Sponsor:
Information provided by:
Valentis
ClinicalTrials.gov Identifier:
NCT00068133
First received: September 8, 2003
Last updated: June 23, 2005
Last verified: May 2005
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Valentis:

Estimated Enrollment: 100
Study Start Date: June 2003
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068133

  Show 20 Study Locations
Sponsors and Collaborators
Valentis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00068133     History of Changes
Other Study ID Numbers: VLTS-589-121
Study First Received: September 8, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013