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

September 8, 2003
June 23, 2005
June 2003
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Complete list of historical versions of study NCT00068133 on ClinicalTrials.gov Archive Site
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Trial of VLTS-589 in Subjects With Intermittent Claudication
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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Intermittent Claudication
  • Peripheral Vascular Disease
Genetic: Plasmid based Gene Transfer product-VLTS-589
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2005
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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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068133
VLTS-589-121
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Valentis
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Valentis
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP