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A 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

NCT02814097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-09-07

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.

Conditions

Interventions

DRUG

elamipretide

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

DRUG

Placebo

Subcutaneous injection of placebo administered once daily for 28 consecutive days

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • SCIRENT Clinical Research and Science d.o.o.

    collaborator UNKNOWN

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-02
Primary Completion
2017-05-04
Completion
2017-06-02

Countries

  • Germany
  • Serbia

Study Locations

More Related Trials

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 NCT02814097 on ClinicalTrials.gov