A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- Valentis
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
Secondary Outcomes
- To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life