Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

Sanofi148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

148

Conditions

Ascites Liver Cirrhosis

Interventions

satavaptan (SR121463B)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Cove, New South Wales, Australia

Sanofi-Aventis Administrative Office

Diegem, Belgium

Outcomes

Primary Outcomes

Change in body weight

Time frame: within 14 days

Secondary Outcomes

Abdominal girth and discomfort

Time frame: 14 days

Paracentesis

Time frame: 14 days

Quality of life

Time frame: 14 days

Data from ClinicalTrials.gov

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