Intermittent ClaudicationPhase 2NCT00068133
Trial of VLTS-589 in Subjects With Intermittent Claudication
A Phase 2 study testing Plasmid based Gene Transfer product-VLTS-589 in people with Intermittent Claudication and Peripheral Vascular Disease, run by Valentis at 20 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Intermittent Claudication, Peripheral Vascular Disease
- What is being tested?
- Plasmid based Gene Transfer product-VLTS-589
- How many people
- 100 participants
- Where
- 20 sitesUnited States
- Study dates
- Jun 2003to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
American Cardiovascular Research Institute
Atlanta, Georgia, 30342
Androscoggin Cardiology Associates
Auburn, Maine, 04210
Access Clinical Trials-Cardiovascular Research
Beverly Hills, California, 90210
Cardiology Pc
Birmingham, Alabama, 35211
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
Duke Clinical Research Institute
Durham, North Carolina, 27715
The Methodist Hospital
Houston, Texas, 77030
The Care Group
Indianapolis, Indiana, 46260
Jacksonville Heart Center
Jacksonville, Florida, 32207
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Minneapolis Heart Institution Foundation
Minneapolis, Minnesota, 55407
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
St. Vincent's Hospital
New York, New York, 10011
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Arizona Heart Institute
Phoenix, Arizona, 85016
Heart Specialists of Sarasota Clinical Research Center
Sarasota, Florida, 34239
Daniel Gottleib, MD
Seattle, Washington, 98166
Prairie Heart Institution at St. John's Hospital
Springfield, Illinois, 62701
About this study
Official title: A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
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.
- Being tested
- Plasmid based Gene Transfer product-VLTS-589
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmid based Gene Transfer product-VLTS-589Genetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2003 (estimated)
- Study startJun 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Valentis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068133
- Sponsor's protocol ID
- VLTS-589-121
- Status last verified
- May 2005
- First submitted
- 8 Sep 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00068133
- Acronym / sponsor ID
- VLTS-589-121
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- ValentisIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Jun 2005
- First posted
- 10 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmid based Gene Transfer product-VLTS-589 | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plasmid based Gene Transfer product-VLTS-589 in people with Intermittent Claudication and Peripheral Vascular Disease, run by Valentis at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.