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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00113009
Other study ID # VLTS-934-123
Secondary ID
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
Est. primary completion date
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


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
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