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NCT01661634 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure

A Phase 3 study of Acute Decompensated Heart Failure, sponsored by Cardiorentis.

Completed
Registry status
Phase 3
Development phase
2,157
Enrollment target
20
Study locations

NCT01661634 is a Phase 3 study of Acute Decompensated Heart Failure that has completed, run by Cardiorentis. The registered enrollment target is 2,157 participants, above the 279-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (673% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT01661634, a Phase 3 study of Acute Decompensated Heart Failure, has completed, sponsored by Cardiorentis.

COMPLETED
Registry status
Phase 3
Development phase
2,157 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

Interventions

  • DRUG Placebo
  • DRUG Ularitide

Study Locations (20)

Michigan

  • - Detroit
  • - Detroit
  • - Detroit
  • - Royal Oak

Alabama

  • - Huntsville
  • - Montgomery

Illinois

  • - Peoria
  • - Rockford

California

  • - Sacramento

Colorado

  • - Littleton

Connecticut

  • - Trumbull

District of Columbia

  • - Washington D.C.

Florida

  • - Jacksonville

Trial Details

FieldValue
Enrollment Target 2,157 participants
Start Date 2012-07
Est. Completion 2016-03
Phase Phase 3

Sponsor

Cardiorentis

1 total trials

What the Registry Record Tells You About NCT01661634

The ClinicalTrials.gov registry entry for NCT01661634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,157 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 279-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (673% higher). The listed sponsor is Cardiorentis, which has 1 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 2 interventions - of which Placebo is the first listed.

NCT01661634 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Michigan, Alabama, Illinois.

Frequently Asked Questions

What is clinical trial NCT01661634 about?

NCT01661634 is a clinical study titled "Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure". The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

What is the current status of trial NCT01661634?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,157 participants. The study started on 2012-07. Estimated completion is 2016-03.

What conditions does trial NCT01661634 study?

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

What interventions are being tested in trial NCT01661634?

The interventions under investigation include: Placebo (DRUG), Ularitide (DRUG).

Who is sponsoring clinical trial NCT01661634?

This trial is sponsored by Cardiorentis, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01661634 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. 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

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