NCT02557217

NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Armaron Bio Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

After someone has a MI, their heart 'remodels', which means that it changes in size and shape. This damage can lead to it being weaker and less efficient, and ultimately to major heart problems. There are some drugs currently available which help prevent remodelling and are used for treatment post-MI. However, there is still a high rate of remodelling and major heart problems in people post-MI. NP202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-MI remodelling. This study will assess NP202 versus placebo on remodelling over a 3 month treatment period, with 1 month follow up

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	NP202	Active
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2015-09-23
• Last updated: 2017-06-28

Locations

1 site across 1 country: Australia