Normo~CAT: Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00501566

Collaborator

(none)

148

Enrollment

Locations

Duration (Months)

12.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ascites Liver Cirrhosis	Drug: satavaptan (SR121463B)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study

Study Start Date :

Apr 1, 2004

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Change in body weight [within 14 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Sanofi-Aventis Administrative Office	Buenos Aires		Argentina
2	Sanofi-Aventis Administrative Office	Cove	New South Wales	Australia
3	Sanofi-Aventis Administrative Office	Diegem		Belgium
4	Sanofi-Aventis Administrative Office	Laval	Quebec	Canada
5	Sanofi-Aventis Administrative Office	Zagreb		Croatia
6	Sanofi-Aventis Administrative Office	Praha		Czech Republic
7	Sanofi-Aventis Administrative Office	Paris		France
8	Sanofi-Aventis Administrative Office	Berlin		Germany
9	Sanofi-Aventis Administrative Office	Budapest		Hungary
10	Sanofi-Aventis Administrative Office	Milan		Italy
11	Sanofi-Aventis Administrative Office	Bucuresti		Romania
12	Sanofi-Aventis Administrative Office	Barcelona		Spain