Overview

The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure

Status:
Unknown status
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
To Assess the safety, tolerability and efficacy of two different doses of istaroxime (0.5 and 1.0 µg/kg/min), a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure. In all the Italian patients and in a subset of Chinese patients pharmacokinetics and metabolism of istaroxime shall also be studied.
Phase:
Phase 2
Details
Lead Sponsor:
Lee's Pharmaceutical Limited
Collaborator:
CVie Therapeutics Co. Ltd.