Trial of VLTS-589 in Subjects With Intermittent Claudication

Valentis

Status and phase

Completed

Phase 2

Conditions

Peripheral Vascular Disease

Intermittent Claudication

Treatments

Genetic: Plasmid based Gene Transfer product-VLTS-589

Study type

Interventional

Funder types

Industry

Identifiers

NCT00068133

VLTS-589-121

Details and patient eligibility

About

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.

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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