drugset / Trial / NCT01755858

Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

NCT01755858

Phase 1/2 Terminated 16 enrolled Stealth BioTherapeutics Inc.
RandomizedParallel-groupTriple-blindBasic science

Summary

This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).

Timeline

Start
2012-12
Primary completion
2015-12
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Elamipretide Peptide 0.05 mg/kg Intravenous