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

Sponsor:	Valentis
Information provided by:	Valentis
ClinicalTrials.gov Identifier:	NCT00113009

Purpose

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.

Condition	Intervention	Phase
Peripheral Vascular Disease	Drug: VLTS-934	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by Valentis:

Primary Outcome Measures:

To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo

Secondary Outcome Measures:

To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life

Estimated Enrollment:	148
Study Start Date:	March 2005
Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	40 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113009

Show 32 Study Locations

Sponsors and Collaborators

Valentis

More Information

No publications provided

Study ID Numbers:	VLTS-934-123
Study First Received:	June 2, 2005
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00113009 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Valentis:

Peripheral arterial disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Signs and Symptoms
Peripheral Vascular Diseases
Vascular Diseases

Intermittent Claudication
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on February 08, 2010