Trial of VLTS-589 in Subjects With Intermittent Claudication

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.

Completed

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Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardiology Pc, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmid based Gene Transfer product-VLTS-589

Genetic

Sponsors and collaborators

Lead sponsor

Valentis

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2005
First posted: Sep 10, 2003
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed