跳至主要内容
临床试验/EUCTR2013-002513-35-IT
EUCTR2013-002513-35-IT进行中(未招募)1 期

A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients. - RELAX AHF_Pan E

OVARTIS FARMA S.p.A.0 个研究点目标入组 2,685 人开始时间: 2013年11月21日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
2,685

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Systolic blood pressure =125 mmHg
  • - Admitted for AHF
  • - Furosemide at any time between admission and the start of screening
  • - eGFR on admission: =30 and =75 mL/min/1.73 m2
  • Other protocol-defined inclusion criteria may apply.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 617
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2068

排除标准

  • - Dyspnea (non-cardiac causes)
  • - T >38.5°C
  • - Clinical evidence of acute coronary syndrome
  • - AHF due to arrhythmias, acute myocarditis or cardiomyopathy
  • Other protocol-defined exclusion criteria may apply.

研究者

发起方
OVARTIS FARMA S.p.A.

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