NCT00366795

Satavaptan for 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 in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients 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: 2006-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-08-21
• Last updated: 2016-05-18

Locations

21 sites across 21 countries: United States, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Singapore, Spain, Turkey (Türkiye)