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.
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.
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.
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).
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