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NCT01966601 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acute Decompensated Heart Failure, sponsored by Trevena.

Completed
Registry status
Phase 2
Development phase
620
Enrollment target
20
Study locations

NCT01966601 is a Phase 2 study of Acute Decompensated Heart Failure that has completed, run by Trevena. The registered enrollment target is 620 participants, above the 407-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (52% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT01966601, a Phase 2 study of Acute Decompensated Heart Failure, has completed, sponsored by Trevena.

COMPLETED
Registry status
Phase 2
Development phase
620 participants
Enrollment target
20
Study locations

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 Studied

Acute Decompensated Heart Failure

Interventions

  • DRUG Placebo
  • DRUG TRV027 Dose #1
  • DRUG TRV027 Dose #2
  • DRUG TRV027 Dose #3

Study Locations (20)

Other

  • Research Site - Buenos Aires
  • Research Site - Coronel Suárez
  • Research Site - Corrientes
  • Research Site - Córdoba
  • Research Site - La Plata
  • Research Site - Morón
  • Research Site - Quilmes
  • Research Site - Rosario
  • Research Site - San Martín
  • Research Site - San Miguel de Tucumán
  • Research Site - Santa Fe
  • Research Site - Dimitrovgrad
  • Research Site - Kazanlak
  • Research Site - Pazardzhik
  • Research Site - Pleven
  • Research Site - Smolyan

Michigan

  • Wayne State University - Detroit

Ohio

  • University of Cincinnati - Cincinnati

Tennessee

  • Tennessee Center for Clinical Trials - Tullahoma

Texas

  • Michael E Debakey VA Medical Center - Houston

Trial Details

FieldValue
Enrollment Target 620 participants
Start Date 2013-12
Est. Completion 2016-09
Phase Phase 2

Sponsor

Trevena

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01966601

The ClinicalTrials.gov registry entry for NCT01966601 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 620 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 407-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (52% higher). The listed sponsor is Trevena, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Decompensated Heart Failure appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01966601 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Michigan, Ohio.

Frequently Asked Questions

What is clinical trial NCT01966601 about?

NCT01966601 is a clinical study titled "A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure". 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).

What is the current status of trial NCT01966601?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 620 participants. The study started on 2013-12. Estimated completion is 2016-09.

What conditions does trial NCT01966601 study?

This clinical trial studies the following conditions: Acute Decompensated Heart Failure.

What interventions are being tested in trial NCT01966601?

The interventions under investigation include: Placebo (DRUG), TRV027 Dose #1 (DRUG), TRV027 Dose #2 (DRUG), TRV027 Dose #3 (DRUG).

Who is sponsoring clinical trial NCT01966601?

This trial is sponsored by Trevena, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01966601 being conducted?

This trial has 20 study locations across Michigan, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.