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Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00113009
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:
Valentis

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Drug: VLTS-934 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  1. To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113009


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
Beverly Hills, California, United States
Los Angeles, California, United States
Mountain View, California, United States
Santa Rosa, California, United States
United States, Florida
Deerfield Beach, Florida, United States
DeLand, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Sarasota, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Houma, Louisiana, United States
Thibodaux, Louisiana, United States
United States, Maine
Auburn, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Flint, Michigan, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Buffalo, New York, United States
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Virgina Beach, Virginia, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Valentis

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ClinicalTrials.gov Identifier: NCT00113009    
Other Study ID Numbers: VLTS-934-123
First Posted: June 3, 2005    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: March 2006
Keywords provided by Valentis:
Peripheral arterial disease
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms