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NCT00358878 · ClinicalTrials.gov registry record · Phase 3

Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

A Phase 3 study of Liver Cirrhosis and Ascites, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
463
Enrollment target
20
Study locations

NCT00358878: Completed Phase 3 study of Liver Cirrhosis and Ascites, sponsored by Sanofi.

NCT00358878 is a Phase 3 study of Liver Cirrhosis and Ascites that has completed, run by Sanofi. The registered enrollment target is 463 participants, below the 974-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00358878, a Phase 3 study of Liver Cirrhosis and Ascites, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
463 participants
Enrollment target
20
Study locations

Study Summary

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Conditions Studied

Liver Cirrhosis Ascites

Interventions

  • DRUG placebo
  • DRUG Satavaptan

Study Locations (20)

Other

  • Sanofi-Aventis Administrative Office - Buenos Aires
  • Sanofi-Aventis Administrative Office - Diegem
  • Sanofi-Aventis Administrative Office - São Paulo
  • Sanofi-Aventis Administrative Office - Santiago
  • Sanofi-Aventis Administrative Office - Zagreb
  • Sanofi-Aventis Administrative Office - Hørsholm
  • Sanofi-Aventis Administrative Office - Paris
  • Sanofi-Aventis Administrative Office - Budapest
  • Sanofi-Aventis Administrative Office - Netanya
  • Sanofi-Aventis Administrative Office - Milan
  • Sanofi-Aventis Administrative Office - Gouda
  • Sanofi-Aventis Administrative Office - Warsaw
  • Sanofi-Aventis Administrative Office - Porto Salvo
  • Sanofi-Aventis Administrative Office - Bucharest
  • Sanofi-Aventis Administrative Office - Moscow
  • Sanofi-Aventis Administrative Office - Madrid
  • Sanofi-Aventis Administrative Office - Bromma

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

New South Wales

  • Sanofi-Aventis Administrative Office - Cove

Quebec

  • Sanofi-Aventis Administrative Office - Laval

Trial Details

FieldValue
Enrollment Target 463 participants
Start Date 2006-07
Est. Completion 2008-12
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00358878 record still lists

NCT00358878 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, below the 974-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (52% lower).

The record links to 2 conditions, with Liver Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00358878 names 20 study sites across 4 states, led by Other, New Jersey, New South Wales.

Frequently Asked Questions

What is clinical trial NCT00358878 about?

NCT00358878 is a clinical study titled "Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)". Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis ...

What is the current status of trial NCT00358878?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 463 participants. The study started on 2006-07. Estimated completion is 2008-12.

What conditions does trial NCT00358878 study?

This clinical trial studies the following conditions: Liver Cirrhosis, Ascites.

What interventions are being tested in trial NCT00358878?

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

Who is sponsoring clinical trial NCT00358878?

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

Where is trial NCT00358878 being conducted?

This trial has 20 study locations across New Jersey, New South Wales, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Liver Cirrhosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00358878's enrollment target sits among peer trials

463 6th of 15 higher than 10 of 15 other Liver Cirrhosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Liver Cirrhosis 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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Related registry views

Source: ClinicalTrials.gov NCT00358878, the US trial registry maintained by the National Library of Medicine. NCT00358878 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.