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A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure

NCT01966601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2018-07-26

No results posted yet for this study

Summary

To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).

Conditions

  • Acute Decompensated Heart Failure

Interventions

DRUG

TRV027 Dose #1

TRV027 continuous intravenous infusion Dose #1

DRUG

TRV027 Dose #2

TRV027 continuous intravenous infusion Dose #2

DRUG

TRV027 Dose #3

TRV027 continuous intravenous infusion Dose #3

DRUG

Placebo

Placebo continuous intravenous infusion

Sponsors & Collaborators

  • Trevena Inc.

    lead INDUSTRY

Principal Investigators

  • David Soergel, MD · Trevena Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Poland
  • Romania
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

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 NCT01966601 on ClinicalTrials.gov