CLINICAL TRIALS PROFILE FOR SATAVAPTAN

Clinical Trials for Satavaptan

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00032734 ↗	Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion	Completed	Sanofi	Phase 2	The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.
NCT00264914 ↗	Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion	Completed	Sanofi	Phase 3	To determine the long-term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.
NCT00264927 ↗	Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion	Completed	Sanofi	Phase 3	To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH. The double blind period is followed by an open label extension study with flexible doses of satavaptan.
NCT00358878 ↗	Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)	Completed	Sanofi	Phase 3	Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
NCT00359437 ↗	Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver	Terminated	Sanofi	Phase 3	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).
NCT00366795 ↗	Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver	Terminated	Sanofi	Phase 3	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).
NCT00501384 ↗	Satavaptan Dose-Ranging Study in the Prevention of Ascites	Completed	Sanofi	Phase 2	The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

Clinical Trial Conditions for Satavaptan

Condition Name

Condition Name for
Intervention	Trials
Ascites	6
Liver Cirrhosis	6
Hyponatremia	4
Inappropriate ADH Syndrome	3

Condition MeSH

Condition MeSH for
Intervention	Trials
Liver Cirrhosis	6
Ascites	6
Hyponatremia	5
Syndrome	4

Clinical Trial Locations for Satavaptan

Trials by Country

Trials by Country for
Location	Trials
Belgium	9
Germany	8
France	8
Canada	8
Australia	7

Trials by US State

Trials by US State for
Location	Trials
New Jersey	5
Pennsylvania	2

Clinical Trial Progress for Satavaptan

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	7
Terminated	3

Clinical Trial Sponsors for Satavaptan

Sponsor Name

Sponsor Name for
Sponsor	Trials
Sanofi	10

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	10