Brief Summary

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent 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

Monitor

Trial Health Score

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

Enrollment

501

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2006

Geographic Reach

24 countries

24 active sites

Status

terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

July 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

Last Updated

May 24, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

August 1, 2006

Last Update Submit

April 25, 2016

Conditions

Ascites Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

Number and time of recurrences of therapeutic paracenteses
up to 12 weeks

Secondary Outcomes (2)

Time from randomisation to first recurrence of ascites
study period
Increase in ascites
over 12 weeks

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 recurrent ascites having undergone both of the following:
therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of \> 4 litres of fluid.
at least one other therapeutic paracentesis in the previous 3 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.