Brief Summary

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites. This Hypo\~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo\~CAT). 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

110

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach

13 countries

13 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

11 months study duration

Study Start

First participant enrolled

April 1, 2004

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed

2.4 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

11 months

First QC Date

July 13, 2007

Last Update Submit

January 9, 2009

Conditions

Ascites Liver Cirrhosis

Keywords

cirrhotic asciteshyponatraemia

Outcome Measures

Primary Outcomes (1)

change in body weight, change in serum sodium
within 14 days

Secondary Outcomes (3)

abdominal girth and discomfort
14 days
paracentesis
14 days
trail-making test and 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
Patients with hyponatremia, defined as a serum sodium concentration 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.