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NCT01292304 · ClinicalTrials.gov registry record · Phase 4

Tolvaptan for Ascites in Cirrhotic Patients

A Phase 4 study, sponsored by University of Florida.

Completed
Registry status
Phase 4
Development phase
10
Enrollment target

NCT01292304: Completed Phase 4 study, sponsored by University of Florida.

NCT01292304 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01292304, a Phase 4 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 4
Development phase
10 participants
Enrollment target

Study Summary

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

Primary Outcome

Increase in number of therapeutic paracentesis (removal of \> 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing

Interventions

  • DRUG Tolvaptan

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2012-03
Est. Completion 2015-01
Phase Phase 4
University of Florida

1,106 total trials

What the finished NCT01292304 record still lists

NCT01292304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.

NCT01292304 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01292304 about?

NCT01292304 is a clinical study titled "Tolvaptan for Ascites in Cirrhotic Patients". Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

What is the current status of trial NCT01292304?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2012-03. Estimated completion is 2015-01.

What interventions are being tested in trial NCT01292304?

The interventions under investigation include: Tolvaptan (DRUG).

Who is sponsoring clinical trial NCT01292304?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01292304's enrollment target sits among peer trials

10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01292304, the US trial registry maintained by the National Library of Medicine. NCT01292304 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.