Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00501566
• Date of registration: 13/07/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites Normo~CAT
• Scientific title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
• Date of first enrolment: April 2004
• Target sample size: 148
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00501566
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Romania, Spain

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Cirrhosis

Ascites

Intervention(s)

Drug: satavaptan (SR121463B)

Primary Outcome(s)

Change in body weight [Time Frame: within 14 days]

Secondary Outcome(s)

Abdominal girth and discomfort [Time Frame: 14 days]

Paracentesis [Time Frame: 14 days]

Quality of life [Time Frame: 14 days]

Secondary ID(s)

DFI5563

SR121463

Source(s) of Monetary Support

Please refer to primary and secondary sponsors