[Translation] A randomized, double-blind, placebo-controlled study evaluating the effects of INL1 (Trientine) in patients with heart failure and reduced ejection fraction
目的:
主要目的:
评价12周时INL1(盐酸曲恩汀)与安慰剂相比在NYHA 心功能分级Ⅱ~Ⅲ级伴左心室射血分数降低(LVEF<40%)的心力衰竭患者中的疗效。
次要目的:
评价INL1(盐酸曲恩汀)与安慰剂相比在心力衰竭患者中的安全性和耐受性。
描述12周治疗期间INL1(盐酸曲恩汀)的药代动力学(PK)特征
[Translation] Objective:
Primary objective:
To evaluate the efficacy of INL1 (trientine hydrochloride) compared with placebo in patients with heart failure of NYHA class II-III with reduced left ventricular ejection fraction (LVEF<40%) at 12 weeks.
Secondary objective:
To evaluate the safety and tolerability of INL1 (trientine hydrochloride) compared with placebo in patients with heart failure.
To describe the pharmacokinetic (PK) characteristics of INL1 (trientine hydrochloride) during 12 weeks of treatment