Clinical Trial: Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
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.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: Change in body weight [ Time Frame: within 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Abdominal girth and discomfort [ Time Frame: 14 days ]
- Paracentesis [ Time Frame: 14 days ]
- Quality of life [ Time Frame: 14 days ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: July 13, 2007
Date Started: April 2004
Date Completion:
Last Updated: July 13, 2007
Last Verified: July 2007
