drugset / Trial / NCT00113009
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
RandomizedSingle-groupDouble-blindTreatment
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.
Timeline
- Start
- 2005-03
- Primary completion
- —
- Completion
- 2006-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vepoloxamer | Small molecule | 420 mg | Intramuscular |