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临床试验/NCT03509545
NCT03509545终止1 期

An Open Label,Crossover Study to Compare Once Daily Dose of 40 mg Torsemide Extended Release to Twice Daily of Furosemide on Natriuresis and Body Weight in Congestive Heart Failure (CHF) Patients Who Are on Stable Dose of Furosemide

Sarfez Pharmaceuticals, Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
20
试验地点
2
主要终点
change in 24-hour sodium excretion compared to baseline

研究概览

简要总结

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.

详细描述

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice-daily Furosemide on changes in body weight after two weeks of treatment. To compare the frequency and volume of urine passed in 24 hours. To compare the patients' quality of life and levels of natriuretic peptide between the two sets of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.

排除标准

  • Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.

研究组 & 干预措施

CHF Patients: ER Torsemide 40 mg

Experimental

CHF patients will be given 40 mg ER Torsemide

干预措施: CHF Patients: ER Torsemide 40 mg (Drug)

CHF Patients: Furosemide 40 mg

Active Comparator

CHF patients are on 40 mg of Furosemide

干预措施: CHF Patients: Furosemide 40 mg (Drug)

结局指标

主要结局

change in 24-hour sodium excretion compared to baseline

时间窗: 24 hours

the difference in 24 hour sodium excretion between ER Torsemide and Furosemide

次要结局

  • Changes in body weight(2 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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