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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014