Brief Summary

The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

Trial Health

On Track

Trial Health Score

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

Enrollment

151

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach

11 countries

11 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

1.1 years study duration

Study Start

First participant enrolled

April 1, 2004

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed

Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

1.1 years

First QC Date

July 13, 2007

Last Update Submit

January 9, 2009

Conditions

Ascites Liver Cirrhosis

Keywords

cirrhotic ascites

Outcome Measures

Primary Outcomes (1)

Time to repeat therapeutic paracentesis
12 weeks

Secondary Outcomes (3)

Increase in ascites judged by body weight and ascites volume
within 12 weeks
frequency of paracentesis
12 weeks
quality of life
12 weeks

Interventions

satavaptan (SR121463B)DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.