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NCT01644331 · ClinicalTrials.gov registry record · Phase 3

Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

A Phase 3 study, sponsored by Duke University.

Completed
Registry status
Phase 3
Development phase
257
Enrollment target

NCT01644331 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 257 participants.

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The verdict

NCT01644331, a Phase 3 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 3
Development phase
257 participants
Enrollment target

Study Summary

The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone

Interventions

  • DRUG Placebo
  • DRUG Tolvaptan

Trial Details

FieldValue
Enrollment Target 257 participants
Start Date 2012-10
Est. Completion 2016-02
Phase Phase 3

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT01644331

The ClinicalTrials.gov registry entry for NCT01644331 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 257 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01644331 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01644331 about?

NCT01644331 is a clinical study titled "Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure". The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be m...

What is the current status of trial NCT01644331?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 257 participants. The study started on 2012-10. Estimated completion is 2016-02.

What interventions are being tested in trial NCT01644331?

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

Who is sponsoring clinical trial NCT01644331?

This trial is sponsored by Duke University, which has 1,725 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.