Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
1 other identifier
interventional
148
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2005
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 2, 2005
CompletedFirst Posted
Study publicly available on registry
June 3, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedNovember 22, 2007
March 1, 2006
June 2, 2005
November 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of peripheral arterial disease in both legs
- History of exercise limiting symptoms
You may not qualify if:
- Lower limb revascularization surgery with 2 months of study entry
- Diagnosis of critical limb ischemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valentislead
Study Sites (32)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Mountain View, California, United States
Unknown Facility
Santa Rosa, California, United States
Unknown Facility
Deerfield Beach, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Houma, Louisiana, United States
Unknown Facility
Thibodaux, Louisiana, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Unknown Facility
Flint, Michigan, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Virgina Beach, Virginia, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2005
First Posted
June 3, 2005
Study Start
March 1, 2005
Study Completion
July 1, 2006
Last Updated
November 22, 2007
Record last verified: 2006-03