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COMPLETED Phase 3

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

NCT01661634 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01661634

The ClinicalTrials.gov registry entry for NCT01661634 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiorentis, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01661634 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Michigan, Alabama, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01661634?

The interventions under investigation include: Placebo (DRUG), Ularitide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01661634?

This trial is sponsored by Cardiorentis, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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