Trial of VLTS-589 in Subjects With Intermittent Claudication - Tabular View

Tracking Information
First Received Date ^ICMJE	September 8, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	June 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00068133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Trial of VLTS-589 in Subjects With Intermittent Claudication
Official Title ^ICMJE	A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Intermittent Claudication Peripheral Vascular Disease
Intervention ^ICMJE	Gene Transfer: Plasmid based Gene Transfer product-VLTS-589
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	June 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00068133
Responsible Party
Study ID Numbers ^ICMJE	VLTS-589-121
Study Sponsor ^ICMJE	Valentis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Valentis
Verification Date	May 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP