Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Sponsor

Sanofi

713 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00358878

The ClinicalTrials.gov registry entry for NCT00358878 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 974-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (52% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Liver Cirrhosis

All registered trials for this condition

Ascites

All registered trials for this condition

New Jersey

All trials with a study site in New Jersey

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.