Trial of VLTS-589 in Subjects With Intermittent Claudication
A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
1 other identifier
interventional
100
1 country
20
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2003
20 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
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2003
CompletedFirst Posted
Study publicly available on registry
September 10, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedJune 24, 2005
May 1, 2005
September 8, 2003
June 23, 2005
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Men or women between 40 and 80 years of age,
- Must give informed consent,
- Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness
You may not qualify if:
- Ulcers or gangrene,
- History of cancer (except skin cancer) within the past 5 years,
- Participation in another clinical trial within 30 days of enrollment in this trial,
- Unwillingness or inability to comply with all study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valentislead
Study Sites (20)
Cardiology Pc
Birmingham, Alabama, 35211, United States
Arizona Heart Institute
Phoenix, Arizona, 85016, United States
Access Clinical Trials-Cardiovascular Research
Beverly Hills, California, 90210, United States
Jacksonville Heart Center
Jacksonville, Florida, 32207, United States
Heart Specialists of Sarasota Clinical Research Center
Sarasota, Florida, 34239, United States
American Cardiovascular Research Institute
Atlanta, Georgia, 30342, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Prairie Heart Institution at St. John's Hospital
Springfield, Illinois, 62701, United States
The Care Group
Indianapolis, Indiana, 46260, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Androscoggin Cardiology Associates
Auburn, Maine, 04210, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
Minneapolis Heart Institution Foundation
Minneapolis, Minnesota, 55407, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
St. Vincent's Hospital
New York, New York, 10011, United States
Duke Clinical Research Institute
Durham, North Carolina, 27715, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Daniel Gottleib, MD
Seattle, Washington, 98166, 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
September 8, 2003
First Posted
September 10, 2003
Study Start
June 1, 2003
Study Completion
June 1, 2005
Last Updated
June 24, 2005
Record last verified: 2005-05