RANDOMIZED, PLACEBO CONTROLLED, SINGLE DOSE STUDY OF INTRAVENOUS CVT 124

静脉 CVT 的随机、安慰剂对照、单剂量研究 124

• 批准号: 6291035
• 负责人: D CRAIG BRATER
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/6291035
• 关键词: clinical research; congestive heart failure; diuresis; diuretics; dosage; drug adverse effect; drug screening /evaluation; electrolytes; heart disorder chemotherapy; human subject; human therapy evaluation; intravenous administration; placebos; urinalysis

The primary objective of this Phase II study is to test the diuretic efficacy of single intravenous doses of CVT-124 at three dose levels in patients with stable NYHA class II and III congestive heart (CHF) assessed by changes in electrolyte excretion, urine volumes, and weight. The secondary objective of this study is to assess the safety and tolerability of a single IV dose of CVT-124 at three dose levels in patients with stable CHF.

这项II期研究的主要目的是测试利尿剂 三个剂量水平的CVT-124的单次静脉内剂量在以下患者中的功效： 评估为NYHA II级和III级充血性心脏病（CHF）稳定的患者 电解质排泄、尿量和体重的变化。 的 本研究的次要目的是评估安全性和耐受性 单次IV剂量的CVT-124在三个剂量水平的患者中， 稳定CHF。