Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

Valentis148 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

148

Conditions

Peripheral Vascular Disease

Interventions

VLTS-934DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (32)

Unnamed facility

Birmingham, Alabama, United States

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

Data from ClinicalTrials.gov

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