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

This study has been completed.
Sponsor:
Information provided by:
Valentis
ClinicalTrials.gov Identifier:
NCT00113009
First received: June 2, 2005
Last updated: November 21, 2007
Last verified: March 2006
History of Changes
  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 2

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

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

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

Keywords provided by Valentis:
Peripheral arterial disease

Additional relevant MeSH terms:
Intermittent Claudication
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on May 19, 2013