Clinical trial NCT00068133: Trial of VLTS-589 in Subjects With Intermittent Claudication
Official title: A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intermittent Claudication
Peripheral Vascular Disease
Lead sponsor: Valentis
Sponsor class: INDUSTRY
First posted: 2003-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology Pc
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Beverly Hills
country: United States
facility: Access Clinical Trials-Cardiovascular Research
state: California
city: Jacksonville
country: United States
facility: Jacksonville Heart Center
state: Florida
city: Sarasota
country: United States
facility: Heart Specialists of Sarasota Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: American Cardiovascular Research Institute
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian St. Luke's Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart Institution at St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institution Foundation
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: St. Vincent's Hospital
state: New York
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: Daniel Gottleib, MD
state: Washington
Study officials:
References: