AS 013 IN LIPID EMULSION IN SUBJECTS W/ SEVERE LIMB ISCHEMIA

AS 013 在脂质乳剂中用于患有严重肢体缺血的受试者

• 批准号: 6265163
• 负责人: JOHN F HANSBROUGH
• 金额: $ 1.15万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265163
• 关键词: acute disease /disorder; amputation; analgesics; artery occlusion; cardiovascular disorder chemotherapy; clinical research; disease /disorder prevention /control; drug administration rate /duration; drug screening /evaluation; emulsions; functional ability; human subject; human therapy evaluation; insulin; ischemia; limbs; neuropathology; opiate alkaloid; peripheral blood vessel disorder; placebos; prodrugs; prostaglandin E; ulcer

Demonstrate the efficacy of 30 or 60 mg per day of AS-013 to placebo in subjects with Fontaine stage IV peripheral arterial occlusive disease (PAOD) utilizing the following assessments: reduction in need for major amputation, time to amputate, incidence of complete target ulcer healing, need for any amputation or PAOD-related surgery, and change in functional status. Also, evaluate the dose response relationship of AS-013 in target population, assess the safety of AS-013, and perform exploratory analyses on the effects of AS-013 on neuropathy, insulin requirement, and opiate analgesic consumption.

通过以下评估，证明每天30或60毫克的AS-013安慰剂对方丹IV期周围动脉闭塞症(PAOD)患者的疗效：主要截肢需求的减少、截肢时间、完全目标溃疡愈合的发生率、是否需要任何截肢或与PAOD相关的手术，以及功能状态的变化。此外，评估AS-013在目标人群中的剂量反应关系，评估AS-013的安全性，并对AS-013对神经病变、胰岛素需求和阿片类止痛药消费的影响进行探索性分析。