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临床试验/EUCTR2019-004186-40-GR
EUCTR2019-004186-40-GR进行中(未招募)1 期

A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure

Bristol-Myers Squibb International Corporation0 个研究点目标入组 72 人开始时间: 2020年8月20日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
72

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

  • -Patients currently hospitalized for acute decompensated heart failure (ADHF)
  • -Patients must be hemodynamically stable, as assessed by the investigator
  • -Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
  • -Women participants must have documented proof that they are not of childbearing potential
  • - A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a WOCBP.
  • - No healthy patients, only subjects
  • 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 25
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 47

排除标准

  • -Acute cardiovascular condition other than heart failure (HF) decompensation
  • -Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
  • -Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
  • -Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis

研究者

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