Clinical trial NCT00113009: Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Official title: A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Vascular Disease
Keywords: Peripheral arterial disease
Lead sponsor: Valentis
Sponsor class: INDUSTRY
First posted: 2005-06-03
Enrollment: 148
Sex: ALL
Minimum age (years): 40
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Detailed description: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with IC will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of peripheral arterial disease in both legs
* History of exercise limiting symptoms

Exclusion Criteria:

* Lower limb revascularization surgery with 2 months of study entry
* Diagnosis of critical limb ischemia

Primary outcomes:
measure: To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
Secondary outcomes:
measure: To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Deerfield Beach
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Houma
country: United States
state: Louisiana
city: Thibodaux
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Flint
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Warwick
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Virgina Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References: