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A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

NCT02914665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2020-07-28

No results posted yet for this study

Summary

This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure

Conditions

Interventions

DRUG

elamipretide

20 mg elamipretide administered intravenously once daily for 7 consecutive days

DRUG

Placebo

Placebo administered intravenously once daily for 7 consecutive days

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2017-11-27
Completion
2017-11-27

Countries

  • Belgium
  • Bulgaria
  • France
  • Hungary
  • Latvia
  • Netherlands
  • Poland
  • Serbia
  • Spain
  • United Kingdom

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 NCT02914665 on ClinicalTrials.gov