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

Valentis

Status and phase: Completed; Phase 2

Conditions: Peripheral Vascular Disease

Treatments: Drug: VLTS-934

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113009

VLTS-934-123

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind