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Completed

NCT Number: NCT00358878

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 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).

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Key information

Conditions

Ascites Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Satavaptan

Drug

oral administration once daily

Other names: SR121463B

Placebo

Drug

oral administration once daily

Primary outcomes

  1. Composite endpoint of ascites worsening

    Time frame: at week 12

Secondary outcomes

  1. Composite endpoint of ascites worsening

    Time frame: at week 24

  2. Increase in ascites

    Time frame: at week 12

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: CATS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2006
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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