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

Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358878

Acronym

CATS

Enrollment

463

Registered

2006-08-01

Start date

2006-07-31

Completion date

2008-12-31

Last updated

2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Liver Cirrhosis

Keywords

Ascites, Liver Cirrhosis

Brief 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).

Interventions

DRUGSatavaptan

oral administration once daily

DRUGplacebo

oral administration once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with cirrhosis of the liver * Participants with clinically evident ascites primarily managed by diet and/or diuretics * Stable treatment of ascites for at least the previous 2 weeks without paracentesis * Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion criteria

* Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt * Known hepatocellular carcinoma * Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma * Participants previously exposed to satavaptan in the past 12 months

Design outcomes

Primary

Measure	Time frame
Composite endpoint of ascites worsening	at week 12

Secondary

Measure	Time frame
Composite endpoint of ascites worsening	at week 24
Increase in ascites	at week 12

Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Denmark, France, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Russia, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026