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

Valentis39 个研究点分布在 1 个国家目标入组 100 人开始时间: 2003年6月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Valentis
入组人数: 100
试验地点: 39

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 40 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究者

发起方

Valentis

申办方类型

Industry

研究点 (39)

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