NCT00359437

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Conditions

• Ascites
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Satavaptan	oral administration once daily
DRUG	placebo	oral administration once daily

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-08-02
• Last updated: 2016-05-24

Locations

24 sites across 24 countries: United States, Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Malaysia, Portugal, Romania, Serbia, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom