Back to resultsTrial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Primary Purpose
Peripheral Vascular Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VLTS-934
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Peripheral arterial disease
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
Sites / Locations
- University of Michigan Health Systems
Outcomes
Primary Outcome Measures
To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
Secondary Outcome Measures
To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00113009
Brief Title
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
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Valentis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
Peripheral arterial disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
148 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VLTS-934
Primary Outcome Measure Information:
Title
To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
Secondary Outcome Measure Information:
Title
To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Mountain View
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Deerfield Beach
State/Province
Florida
Country
United States
City
DeLand
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Melbourne
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Houma
State/Province
Louisiana
Country
United States
City
Thibodaux
State/Province
Louisiana
Country
United States
City
Auburn
State/Province
Maine
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Flint
State/Province
Michigan
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Virgina Beach
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
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