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NCT00366795 · ClinicalTrials.gov registry record · Phase 3

Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

A Phase 3 study, sponsored by Sanofi.

Terminated
Registry status
Phase 3
Development phase
241
Enrollment target

NCT00366795: Clinical Trial Phase 3 study, sponsored by Sanofi.

NCT00366795 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 241 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00366795, a Phase 3 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 3
Development phase
241 participants
Enrollment target

Study Summary

Primary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Interventions

  • DRUG placebo
  • DRUG Satavaptan

Trial Details

FieldValue
Enrollment Target 241 participants
Start Date 2006-08
Est. Completion 2008-12
Phase Phase 3
Sanofi

713 total trials

Why NCT00366795 stopped before completion

NCT00366795 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

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

NCT00366795 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00366795 about?

NCT00366795 is a clinical study titled "Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver". Primary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrho...

What is the current status of trial NCT00366795?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2006-08. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00366795?

The interventions under investigation include: placebo (DRUG), Satavaptan (DRUG).

Who is sponsoring clinical trial NCT00366795?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00366795's enrollment target sits among peer trials

241 1272nd of 2000 higher than 728 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00366795, the US trial registry maintained by the National Library of Medicine. NCT00366795 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.