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NCT02646540 · ClinicalTrials.gov registry record · Phase 1

AiDing Diuresis wIth Tolvaptan (ADD-IT)

A Phase 1 study, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT02646540 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 14 participants.

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The verdict

NCT02646540, a Phase 1 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.

Interventions

  • DRUG Tolvaptan 30 mg + IV Diuretics
  • DRUG Metolazone 5 mg + IV Diuretics
  • DRUG 2.5 times the Diuretics Dose

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2016-01
Est. Completion 2018-12-30
Phase Phase 1

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT02646540

The ClinicalTrials.gov registry entry for NCT02646540 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Tolvaptan 30 mg + IV Diuretics is the first listed.

NCT02646540 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02646540 about?

NCT02646540 is a clinical study titled "AiDing Diuresis wIth Tolvaptan (ADD-IT)". The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The i...

What is the current status of trial NCT02646540?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-01. Estimated completion is 2018-12-30.

What interventions are being tested in trial NCT02646540?

The interventions under investigation include: Tolvaptan 30 mg + IV Diuretics (DRUG), Metolazone 5 mg + IV Diuretics (DRUG), 2.5 times the Diuretics Dose (DRUG).

Who is sponsoring clinical trial NCT02646540?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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

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.