Brief Summary

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

Trial Health

On Track

Trial Health Score

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

Enrollment

148

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach

12 countries

12 active sites

Status

completed

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

9 months study duration

Study Start

First participant enrolled

April 1, 2004

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed

2.5 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

July 16, 2007

Status Verified

July 1, 2007

First QC Date

July 13, 2007

Last Update Submit

July 13, 2007

Conditions

Ascites Liver Cirrhosis

Keywords

cirrhotic ascites

Outcome Measures

Primary Outcomes (1)

Change in body weight
within 14 days

Secondary Outcomes (3)

Abdominal girth and discomfort
14 days
Paracentesis
14 days
Quality of life
14 days

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
Moderate or tense ascites
Serum sodium of \>130 mmol/l.
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.