ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Trial of VLTS-589 in Subjects With Intermittent Claudication

This study has been completed.

Sponsored by: Valentis
Information provided by: Valentis
ClinicalTrials.gov Identifier: NCT00068133
  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
Gene Transfer: Plasmid based Gene Transfer product-VLTS-589
Phase II

MedlinePlus related topics:   Peripheral Arterial Disease    Vascular Diseases   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

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  Show 20 Study Locations

Sponsors and Collaborators
Valentis
  More Information


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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Signs and Symptoms
Peripheral Vascular Diseases
Vascular Diseases
Neoplasm Metastasis
Intermittent Claudication
Arteriosclerosis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers