A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral Tonapofylline in Patients With Heart Failure and Renal Insufficiency

Biogen0 个研究点目标入组 34 人开始时间: 2009年2月最近更新: 2023年9月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Biogen
入组人数: 34
主要终点: To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to determine the safety and tolerability of tonapofylline (BG9928) when given at different doses to patients with heart failure and renal insufficiency.

This study will also explore:

Disease related quality-of-life
Exercise capacity
Renal function
Concomitant medications

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age or older
•Diagnosis of heart failure requiring hospitalization >1 and ≤12 months prior to screening
•NYHA Class III or IV at the time of screening
•Renal insufficiency as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2
•Negative pregnancy test

排除标准

•History of an allergic reaction to any xanthine-containing compound.
•History of seizure
•History of stroke
•Serious systemic infection
•Sustained systolic blood pressure >170 or <90 mmHg
•Myocardial infarction within 30 days of Day 1
•Hemodynamically destabilizing arrhythmia within 30 days of Day 1
•Uncorrected hemodynamically significant primary valvular disease
•Known obstructive or restrictive cardiomyopathy
•Cardiac surgery within 60 days prior to Day 1
•Likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
•Evidence of malignancy within 6 months prior to Day
•Participation in any other investigational study of drugs or devices within 30 days prior to Day
•Receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
•Presence of any clinically significant condition that might interfere with optimal safe participation in this study