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Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

NCT02788747 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-05-14

Study results available
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Summary

This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).

Conditions

Interventions

DRUG

4 mg elamipretide

Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days

DRUG

40 mg elamipretide

Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days

DRUG

Placebo

Subcutaneous injection of placebo administered once daily for 28 consecutive days

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Gerasimos Filippatos, MD · University of Athens, School of Medicine, Athens, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-09-30
Completion
2017-10-31

Countries

  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788747 on ClinicalTrials.gov