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

Peripheral Vascular Disease Clinical Trial

Official title:

A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113009
• Other study ID #: VLTS-934-123
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2005
• Last updated: November 21, 2007
• Start date: March 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2006
• Source: Valentis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• VLTS-934

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Valentis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
Secondary	To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life