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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014