MedDataX Logo

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

NCT ID: NCT00113009

Last Updated: 2007-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Peripheral arterial disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VLTS-934

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Valentis

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham, Alabama, United States

Site Status

Beverly Hills, California, United States

Site Status

Los Angeles, California, United States

Site Status

Mountain View, California, United States

Site Status

Santa Rosa, California, United States

Site Status

Deerfield Beach, Florida, United States

Site Status

DeLand, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Melbourne, Florida, United States

Site Status

Sarasota, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Houma, Louisiana, United States

Site Status

Thibodaux, Louisiana, United States

Site Status

Auburn, Maine, United States

Site Status

Baltimore, Maryland, United States

Site Status

University of Michigan Health Systems

Ann Arbor, Michigan, United States

Site Status

Flint, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Buffalo, New York, United States

Site Status

New York, New York, United States

Site Status

Asheville, North Carolina, United States

Site Status

Akron, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Portland, Oregon, United States

Site Status

Warwick, Rhode Island, United States

Site Status

Nashville, Tennessee, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Norfolk, Virginia, United States

Site Status

Virgina Beach, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VLTS-934-123

Identifier Type: -

Identifier Source: org_study_id