A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults Who Have Left Ventricular Systolic Dysfunction Following Myocardial Infarction

Armaron [NCT02557217]

Description: NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a treatment for people after they have had a heart attack (MI).

Drug: NP202; Other: Placebo

Primary Investigator: Kereiakes

Drug/Device Information
Phase II study of the efficacy, safety and tolerability of oral NP202 in adults who have left ventricular systolic dysfunction following myocardial infarction
NP202 is a synthetic flavonol and the mechanism of action is thought to be inhibition of pro-apoptotic kinases of the death-associated protein kinase family
Randomized in a 1:1 ratio to NP202 1000 mg once daily for 3 months or placebo once daily for 3 months
Armaron Bio Pty Ltd
Major Inclusion and Exclusion
Are aged 18 to 80 years, inclusive
Anterior STEMI in the previous 5 days
Have left ventricular dysfunction post STEMI as evidenced by LVEF ≤ 45%
No known cardiomyopathy or heart failure prior to MI
No daily use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or cyclooxygenase-2 (COX-2) inhibitors in the past month
No presence of device/hardware incompatible with MR imaging
No eGFR <30ml/min