Trial of VLTS-589 in Subjects With Intermittent Claudication - Full Text View

Purpose

The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.

Condition	Intervention	Phase
Intermittent Claudication Peripheral Vascular Disease	Gene Transfer: Plasmid based Gene Transfer product-VLTS-589	Phase II

MedlinePlus related topics:

Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

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

Official Title:	A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

Further study details as provided by Valentis:

Estimated Enrollment:	100
Study Start Date:	June 2003
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Men or women between 40 and 80 years of age,
Must give informed consent,
Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness

Exclusion criteria:

Ulcers or gangrene,
History of cancer (except skin cancer) within the past 5 years,
Participation in another clinical trial within 30 days of enrollment in this trial,
Unwillingness or inability to comply with all study requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068133

Show 20 Study Locations

Sponsors and Collaborators

Valentis

More Information

Study ID Numbers:	VLTS-589-121
First Received:	September 8, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00068133
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases

Signs and Symptoms

Peripheral Vascular Diseases

Vascular Diseases

Neoplasm Metastasis

Intermittent Claudication

Arteriosclerosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Valentis
Information provided by:	Valentis
ClinicalTrials.gov Identifier:	NCT00068133