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

Tracking Information
First Received Date ^ICMJE	June 2, 2005
Last Updated Date	November 21, 2007
Start Date ^ICMJE	March 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00113009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Official Title ^ICMJE	A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Brief 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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Peripheral Vascular Disease
Intervention ^ICMJE	Drug: VLTS-934
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	148
Completion Date	July 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 78 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00113009
Other Study ID Numbers ^ICMJE	VLTS-934-123
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Valentis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Valentis
Verification Date	March 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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