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NCT00113009 · ClinicalTrials.gov registry record · Phase 2
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
A Phase 2 study of Peripheral Vascular Disease, sponsored by Valentis.
- Completed
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
- 20
- Study locations
NCT00113009: Completed Phase 2 study of Peripheral Vascular Disease, sponsored by Valentis.
NCT00113009 is a Phase 2 study of Peripheral Vascular Disease that has completed, run by Valentis. The registered enrollment target is 148 participants, below the 276-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113009, a Phase 2 study of Peripheral Vascular Disease, has completed, sponsored by Valentis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG VLTS-934
Study Locations (20)
Florida
- - Deerfield Beach
- - DeLand
- - Jacksonville
- - Melbourne
- - Sarasota
California
- - Beverly Hills
- - Los Angeles
- - Mountain View
- - Santa Rosa
Louisiana
- - Houma
- - Thibodaux
Michigan
- University of Michigan Health Systems - Ann Arbor
- - Flint
Alabama
- - Birmingham
Georgia
- - Atlanta
Illinois
- - Chicago
Maine
- - Auburn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
What the finished NCT00113009 record still lists
NCT00113009 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 1 intervention - of which VLTS-934 is the first listed.
NCT00113009 names 20 study sites across 11 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT00113009 about?
NCT00113009 is a clinical study titled "Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease". 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 intramuscula...
What is the current status of trial NCT00113009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2005-03. Estimated completion is 2006-07.
What conditions does trial NCT00113009 study?
This clinical trial studies the following conditions: Peripheral Vascular Disease.
What interventions are being tested in trial NCT00113009?
The interventions under investigation include: VLTS-934 (DRUG).
Who is sponsoring clinical trial NCT00113009?
This trial is sponsored by Valentis, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00113009 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Peripheral Vascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00113009's enrollment target sits among peer trials
148 13th of 25 higher than 13 of 25 other Peripheral Vascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Vascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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