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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00113009
First Posted: June 3, 2005
Last Update Posted: November 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valentis
  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
Intervention Model: Single Group Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113009


  Show 32 Study Locations
Sponsors and Collaborators
Valentis
  More Information

ClinicalTrials.gov Identifier: NCT00113009     History of Changes
Other Study ID Numbers: VLTS-934-123
First Submitted: June 2, 2005
First Posted: June 3, 2005
Last Update Posted: November 22, 2007
Last Verified: March 2006

Keywords provided by Valentis:
Peripheral arterial disease

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