Aim
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment with Subcutaneous Elamipretide on Left Ventricular Function in Subjects with Stable Heart Failure with Preserved Ejection Fraction
Study Phase: Phase 2
Study Number: SPIHF-203
EudraCT Number: 2015-005615-32
Sponsor:
Stealth BioTherapeutics Inc.
275 Grove Street, Suite 3-107
Newton, MA 02466 Unites States of America
Patient collective
Patients with stable heart failure with preserved ejection fraction (HFpEF)
Study procedure
This is a randomized, double-blinded, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF). After completing the screening period, 46 subjects will be randomized, in a 1:1 ratio, to receive either 40 mg elamipretide once daily or placebo for 28 consecutive days on top of usual care .
Patients enrolled in study
47
Study centers
9 centers in two countries (Germany and Serbia)
Enrollment
7/2016 – 3/2017
Follow-up
7-days Follow-up (apr 2017)
Accepted duties
Project start up activities
Site preparation
Site monitoring
Safety (AE/SAE) management
Archiving
