NCT00358878|CompletedPhase 3

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

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

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC4492EudraCT : 2006-000132-27LTS10036

Study Type

interventional

Target

463

Locations

21 countries

Sites

Timeline

RegisteredAug 2006

StartedJul 2006

CompletionDec 2008

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

463

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2006

Geographic Reach

21 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

July 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

2.4 years

First QC Date

July 31, 2006

Last Update Submit

April 26, 2016

Conditions

Ascites Liver Cirrhosis

Keywords

AscitesLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

Composite endpoint of ascites worsening
at week 12

Secondary Outcomes (2)

Composite endpoint of ascites worsening
at week 24
Increase in ascites
at week 12

Study Arms (2)

Satavaptan

EXPERIMENTAL

Drug: Satavaptan

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SatavaptanDRUG

oral administration once daily

Also known as: SR121463B

Satavaptan

placeboDRUG

oral administration once daily

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.