SAFETY AND EFFECTIVENESS OF IV ADMINISTRATION OF TRK820 IN HYPONATREMIA/CHF PTS

TRK820 静脉注射治疗低钠血症/CHF PTS 的安全性和有效性

• 批准号: 6275422
• 负责人: WILLIAM T ABRAHAM
• 金额: $ 3.14万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275422
• 关键词: cardiotonic agents; clinical research; congestive heart failure; drug screening /evaluation; heart disorder chemotherapy; human subject; human therapy evaluation; hyponatremia; pharmacokinetics

This is a phase II, randomized, ulticenter, double-blind, placebo controlled, parallel group, dose-response study of the pharmacodynamics, pharmacokinetics, safety and tolerance to trk-820 in patients with chf and hyponatremia. The specific aims AR L. To assess the renal, neurohormonal and systemic hemodynamic effects of trk-820 in chf patients; 2. To determine the acute effect of trk-820 on the dilutional hyponatremia of chr; 3. To determine the pharmacokinetics of trk-820 in patients with chf, and 4. To evaluate the safety of trk-820 in patients with chf.

这是一种II期随机、多中心、双盲、安慰剂 对照，平行组，药效学剂量-反应研究， 充血性心力衰竭患者对trk-820的药代动力学、安全性和耐受性 低钠血症。具体目的是AR L.评估肾脏、神经激素 以及trk-820对充血性心力衰竭患者的全身血流动力学影响； TRK-820对小鼠稀释性低钠血症的急性作用 为了确定trk-820在CHF患者中的药代动力学， 4.评价trk-820治疗充血性心力衰竭的安全性。